PHARMACYS PRESCRIPTION 4.5 OZ CREAMY PETROLEUM JELLY- white petrolatum jelly 
American Consumer Products Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Pharmacys Prescription 4.5 OZ Creamy Petroleum Jelly

Active Ingredient

Active ingredient:

Petrolatum 30%

Purpose

Purpose:

Skin Protectant

Uses:

Temporarily protects minor: cuts, scrapes, burns.

Temporarily protects and helps relieve chapped or cracked skin.

Helps protect from the drying effects of wind and cold weather.

Warnings

Warnings

For external use only

Keep out of reach of children

Keep out of reach of children:

If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

Inactive Ingredients: Water (aqua), Mineral Oil, Glycerin, Cetearyl Alcohol, Cetyl Alcohol, Stearyl Alcohol, Glyceryl Stearate, Fragrance, Polysorbate 80, Laureth-20, BHT, Methylparaben, Propylparaben, Dimethicone, Tocopherol.

Directions

Directions apply as needed.

Do not use on deep puncture wounds, animal bites, serious burns.

Stop use and ask a doctor

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

Indications & Usage

When using this product do not get into eyes.

Pharmacys Prescription 4.5 OZ Creamy Petroleum Jelly

Creamy Petroleum Jelly

PHARMACYS PRESCRIPTION 4.5 OZ CREAMY PETROLEUM JELLY 
white petrolatum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72197-016
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LAURETH-20 (UNII: 6SU0SC83AH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MINERAL OIL (UNII: T5L8T28FGP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72197-016-04127.57 g in 1 TUBE; Type 0: Not a Combination Product09/17/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/17/2019
Labeler - American Consumer Products Corp (081101181)

Revised: 9/2019
Document Id: 92c63f9d-7a79-0ce1-e053-2a95a90a274a
Set id: 91465fed-556d-debb-e053-2a95a90af1a9
Version: 2
Effective Time: 20190917
 
American Consumer Products Corp