Label: XTRACARE CREAMY PETROLEUM JELLY- petrolatum jelly
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Contains inactivated NDC Code(s)
NDC Code(s): 58503-061-01 - Packager: China Ningbo Shangge Cosmetic Technology Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated September 13, 2019
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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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
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
XTRACARE CREAMY PETROLEUM JELLY
petrolatum jellyProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58503-061 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:58503-061-01 127 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 - China Ningbo Shangge Cosmetic Technology Corp (529287434) Establishment Name Address ID/FEI Business Operations China Ningbo Shangge Cosmetic Technology Corp 529287434 manufacture(58503-061)