Health Smart Creamy Cocoa Butter Petroleum Jelly

Active Ingredient

Petrolatum 30%

Purpose

Skin Protectant

Uses

temporarily protects minor; cuts, scrapes or burns.
temporarily protects and helps relieve chapped or cracked skin.
helps protect from the drying effects of wind and cold weather.

Warnings

For external use only.

When using this product do not get into eyes.

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.

Do not use on

deep puncture wounds
animal bites
serious burns

Keep out of reach of children

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

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, fragrance, cocoa butter.

PRINCIPAL DISPLAY PANEL

HEALTH SMART CREAMY COCOA BUTTER PETROLEUM JELLY

NET WT. 4.5 OZ. (128G)

PRINCIPAL DISPLAY PANEL

HEALTH SMART CREAMY COCOA BUTTER PETROLEUM
petroleum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52862-019
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	30 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)
COCOA BUTTER (UNII: 512OYT1CRR)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52862-019-33	128 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/10/2014

Labeler - International Wholesale Inc dba Home Smart Products (161872676)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Name	Address	ID/FEI	Business Operations
Establishment
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(52862-019)