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Petroleum Recall

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Side Effects & Adverse Reactions

For external use only

deep or puncture wounds
animal bites
serious burns

condition worsens
systems last longer than 7 days or clear up and occur again within a few days

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

helps treat and prevent diaper rash
protects chafed skin due to diaper rash
helps seal out wetness

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History

There is currently no drug history available for this drug.

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Other Information

There are no additional details available for this product.

Sources

Petroleum Manufacturers

H-e-b

Petroleum | H-e-b

change wet and soiled diapers promptly cleanse the diaper area, and allow to dry apply product liberally as often as necessary, with each diaper change, and especially at bedtime or anytime when exposure to wet diapers may be prolonged

No Recall
Big Lots

Petroleum | Big Lots

apply as needed

No Recall
Salado Sales, Inc

Petroleum | American Health Packaging

(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY. )
Adults Infection* Recommended Dose/Duration of Therapy * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)
Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated)

500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.

Acute bacterial exacerbations of chronic
obstructive pulmonary disease (mild to moderate)

500 mg QD × 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.

Acute bacterial sinusitis

500 mg QD × 3 days

Genital ulcer disease (chancroid)

One single 1 gram dose

Non-gonoccocal urethritis and cervicitis

One single 1 gram dose

Gonococcal urethritis and cervicitis

One single 2 gram dose

Azithromycin tablets can be taken with or without food.
Renal Insufficiency
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC 0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency. )
Hepatic Insufficiency
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)

No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations. )
Pediatric Patients
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute Bacterial Sinusitis
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
Community-Acquired Pneumonia
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)

PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS—Pediatric Use .) Based on Body Weight
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1 Days 2–5 Day 1 Days 2–5 * Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
5

11

2.5 mL
(½ tsp)

1.25 mL
(¼ tsp)

7.5 mL

150 mg

10

22

5 mL
(1 tsp)

2.5 mL
(½ tsp)

15 mL

300 mg

20

44

5 mL
(1 tsp)

2.5 mL
(½ tsp)

15 mL

600 mg

30

66

7.5 mL
(1½ tsp)

3.75 mL
(¾ tsp)

22.5 mL

900 mg

40

88

10 mL
(2 tsp)

5 mL
(1 tsp)

30 mL

1200 mg

50 and above

110 and above

12.5 mL
(2½ tsp)

6.25 mL
(1¼ tsp)

37.5 mL

1500 mg
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1–3 Day 1–3 * Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
5

11

2.5 mL
(1/2 tsp)

7.5 mL

150 mg

10

22

5 mL
(1 tsp)

15 mL

300 mg

20

44

5 mL
(1 tsp)

15 mL

600 mg

30

66

7.5 mL
(1 ½ tsp)

22.5 mL

900 mg

40

88

10 mL
(2 tsp)

30 mL

1200 mg

50 and above

110 and above

12.5 mL
(2 ½ tsp)

37.5 mL

1500 mg
OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1
5

11

3.75 mL
(3/4 tsp)

3.75 mL

150 mg

10

22

7.5 mL
(1 ½ tsp)

7.5 mL

300 mg

20

44

15 mL
(3 tsp)

15 mL

600 mg

30

66

22.5 mL
(4 ½ tsp)

22.5 mL

900 mg

40

88

30 mL
(6 tsp)

30 mL

1200 mg

50 and above

110 and above

37.5 mL
(7 ½ tsp)

37.5 mL

1500 mg

The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)

PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS—Pediatric Use.) Based on Body Weight
PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1–5
8

18

2.5 mL
(½ tsp)

12.5 mL

500 mg

17

37

5 mL
(1 tsp)

25 mL

1000 mg

25

55

7.5 mL
(1½ tsp)

37.5 mL

1500 mg

33

73

10 mL
(2 tsp)

50 mL

2000 mg

40

88

12.5 mL
(2½ tsp)

62.5 mL

2500 mg

No Recall
Delon Laboratories (1990) Ltd

Petroleum | Delon Laboratories (1990) Ltd

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
International Wholesale Inc.

Petroleum | International Wholesale Inc.

DIRECTIONS: Apply to clean & dry area as necessary.

No Recall
Dolgencorp Llc

Petroleum | Dolgencorp Llc

Directions apply as needed

No Recall
Demoulas Supermarkets, Inc

Petroleum | Demoulas Supermarkets, Inc

Directions
change wet and soilded diapers promptly cleanse the diaper area, and allow to dry apply product liberally as often as necessary, with each diaper change, and expecially at bedtime or anytime when exposure to wet diapers may be prolonged

No Recall
H E B

Petroleum | H E B

Directions
change wet and soiled diapers promptly cleanse the diaper area, and allow to dry apply product liberally as often as necessary, with each diaper change, and especially at bedtime or anytime when exposure to wet diapers may be prolonged

No Recall
Personal Care Products

Petroleum | Personal Care Products

Directions

change and cleanse diaper area, and allow to dry

apply product as needed, with each diaper change, especially at bedtime and when exposure to wet diapers may be prolonged.

No Recall
Walgreen Co

Petroleum | Walgreen Co

Apply as needed

No Recall
Topco Associates, Llc

Petroleum | Topco Associates, Llc

change wet and soilded diapers promptly cleanse the diaper area, and allow to dry apply product liberally as often as necessary, with each diaper change, and expecially at bedtime or anytime when exposure to wet diapers may be prolonged

No Recall
Harris Teeter

Petroleum | Harris Teeter

Apply as needed

No Recall
Cvs Pharmacy

Petroleum | Cvs Pharmacy

apply as needed

No Recall
Geiss, Destin And Dunn, Inc

Petroleum | Geiss, Destin And Dunn, Inc

Apply as needed

No Recall
Onpoint, Inc

Petroleum | Onpoint, Inc

apply as needed

No Recall
Kroger Co

Petroleum | Kroger Co

apply as needed

No Recall
Cvs Pharmacy

Petroleum | Cvs Pharmacy

apply as needed

No Recall
Medline Industries, Inc.

Petroleum | Medline Industries, Inc.

• apply as needed.

No Recall
H E B

Petroleum | H E B

change wet and soiled diapers promptly cleanse the diaper area, and allow to dry apply product liberally as often as necessary, with each diaper change, and especially at bedtime or anytime when exposureto wet diapers may be prolonged

No Recall
Supervalu, Inc

Petroleum | Supervalu, Inc

apply as needed

No Recall
Cardinal Health

Petroleum | Cardinal Health

apply as needed.

No Recall