HEALTH SMART CREAMY PETROLEUM- petroleum jelly 
International Wholesale Inc dba Home Smart Products

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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Health Smart Creamy Petroleum Jelly

Active Ingredient

Petrolatum 30%

Purpose

Skin Protectant

Uses

Warnings

For external use only.

When using this product do not get into eyes.

Stop use and ask a doctor if

Do not use on

Keep out of reach of children

Directions

apply as needed.

Inactive Ingredients

water (aqua), carbopol 940, stearic acid, glyceryl monostearate, mineral oil, cetearyl alcohol, GE125 emulsifying agent, methylparaben, propylparaben, triethanolamine, tocopheryl acetate.

PRINCIPAL DISPLAY PANEL

HEALTH SMART CREAMY PETROLEUM JELLY

NET WT. 4.5 OZ. (128G)

PRINCIPAL DISPLAY PANEL

HEALTH SMART CREAMY PETROLEUM 
petroleum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-018
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
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
MINERAL OIL (UNII: T5L8T28FGP)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TROLAMINE (UNII: 9O3K93S3TK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52862-018-33128 g in 1 TUBE; Type 0: Not a Combination Product08/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/10/2014
Labeler - International Wholesale Inc dba Home Smart Products (161872676)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52862-018)

Revised: 1/2022
Document Id: d6dd3735-9c20-f906-e053-2a95a90a3ec0
Set id: 2f9b5662-c47c-4886-aa83-83aee2b900be
Version: 3
Effective Time: 20220131
 
International Wholesale Inc dba Home Smart Products