HEALTH SMART CREAMY COCOA BUTTER PETROLEUM- petroleum jelly

Health Smart Creamy Cocoa Butter Petroleum by

Drug Labeling and Warnings

Health Smart Creamy Cocoa Butter Petroleum by is a Otc medication manufactured, distributed, or labeled by International Wholesale Inc dba Home Smart Products, Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Petrolatum  30%

PURPOSE

Purpose

Skin Protectant

INDICATIONS & USAGE

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

Warnings

For external use only.

WHEN USING

When using this product do not get into eyes.

STOP USE

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

Do not use on

• deep puncture wounds
• animal bites
• serious burns

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.

DOSAGE & ADMINISTRATION

Directions

apply as needed.

INACTIVE INGREDIENT

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.

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

HEALTH SMART CREAMY COCOA BUTTER PETROLEUM JELLY

NET WT. 4.5 OZ. (128G)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52862-019-33	128 g in 1 TUBE

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

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

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

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