XTRACARE CREAMY PETROLEUM JELLY- petrolatum jelly

XtraCare Creamy Petroleum Jelly by

Drug Labeling and Warnings

XtraCare Creamy Petroleum Jelly by is a Otc medication manufactured, distributed, or labeled by Rejoice International, China Ningbo Shangge Cosmetic Technology Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:                                  Purpose

Petrolatum 30% ........................... Skin Protectant

PURPOSE

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

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.

INDICATIONS & USAGE

XtraCare® Creamy Petroleum Jelly

Vitamin E Enriched

Skin Softener

Dry Skin Relief

Absorbs Quickly

Fragrance Free

*Compare to the active ingredient in Vaseline® Petroleum Jelly Cream

Net Wt 4.5oz (127g)

XtraCare®

XtraCare Creamy Petroleum Jelly is specially formulated to moisturize, soften and soothe dry skin. Blended with Vitamin E to produce a rich creamy moisturizer. Use on hands, knees, feet and heels to smooth away dryness. Great for moisturizing face and neck.

WARNINGS

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

DOSAGE & ADMINISTRATION

Directions apply as needed.

INACTIVE INGREDIENT

Inactive Ingredients

water, carbomer, stearic acid, mineral oil, cetyl alcohol, glycerin, ceteareth-20, glyceryl monostearate, methylparaben, propylparaben, DMDM hydantoin, triethanolamine, disodium EDTA, ethylene brassylate, tocopheryl acetate.

OTHER SAFETY INFORMATION

Other Information store at room temperature.

Questions/Comments? 1-855-345-5575

*this product is not manufactured or distributed by UNILEVER, distributor of the registered trademark Vaseline®

DISTRIBUTED BY

REJOICE INTERNATIONAL INC

NORTHVILLE, MI 48168 USA

MADE IN CHINA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XTRACARE CREAMY PETROLEUM JELLY 
petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-061
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	38 g  in 127 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
STEARIC ACID (UNII: 4ELV7Z65AP)
MINERAL OIL (UNII: T5L8T28FGP)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DMDM HYDANTOIN (UNII: BYR0546TOW)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57337-061-01	127 g in 1 PACKAGE; Type 0: Not a Combination Product	02/18/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/18/2014

Labeler - Rejoice International (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetic Technology Corp		529287434	manufacture(57337-061)