COCOA BUTTER PETROLEUM JELLY- petrolatum cream

COCOA BUTTER PETROLEUM jelly by

Drug Labeling and Warnings

COCOA BUTTER PETROLEUM jelly by is a Otc medication manufactured, distributed, or labeled by Savvy Care & Cosmetics Pvt. Ltd., Savvy Care And Cosmetics Pvt Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​Drug Facts

Active ingredient:

Petrolatum 30%

​Purpose

Skin Protectant

​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

​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), mineral oil, glycerin, cetearyl alcohol, cetyl alcohol, stearyl alcohol, glyceryl stearate, fragrance, polysorbate 80, laureth-20, BHT, methylparaben, propylparaben, dimethicone, tocopherol.

SPL UNCLASSIFIED SECTION

New

Vitamin E

Moisturizing

with Cocoa Butter Extra Rich

​Compare to the active ingredient of Vaseline ​®​Petroleum Jelly Cream*

Tones, softens & smooths dry skin

Label

INGREDIENTS AND APPEARANCE

COCOA BUTTER PETROLEUM JELLY 
petrolatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83650-104
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 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
LAURETH-20 (UNII: 6SU0SC83AH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83650-104-01	133 mL in 1 TUBE; Type 0: Not a Combination Product	07/27/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	07/27/2015

Labeler - Savvy Care & Cosmetics Pvt. Ltd. (915039748)

Establishment
Name	Address	ID/FEI	Business Operations
Savvy Care And Cosmetics Pvt Ltd		915039748	manufacture(83650-104)