LUCKY SUPER SOFT COCOA BUTTER- white petrolatum cream 
Anicare Pharmaceuticals Pvt. Ltd.

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.

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super soft cream

Active ingredient

White petrolatum USP (30%)

Purpose

Skin protectant

Uses

■ temporarily protects minor ■ cuts ■ scrapes ■ burns ■ temporarily protects and helps relieve chapped or cracked skin ■ helps prevent and 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 in a few days

Do not use on

■ deep or 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, cetearyl alcohol, ceteareth 20, glycerin, mineral oil, fragrance, benzyl alcohol, methylchloroisothaizolinone, methylisothaizolinone, titanium dioxide, citric acid, tocopheryl acetate, theobroma cacao seed butter, FDC yellow no 6, DC red no 33, FDC yellow no 5, FDC blue no 1

Package Label

Package Label

LUCKY SUPER SOFT  COCOA BUTTER
white petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47046-170
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
GLYCERIN (UNII: PDC6A3C0OX)  
MINERAL OIL (UNII: T5L8T28FGP)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
COCOA BUTTER (UNII: 512OYT1CRR)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47046-170-01127 g in 1 TUBE; Type 0: Not a Combination Product03/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/01/2015
Labeler - Anicare Pharmaceuticals Pvt. Ltd. (916837425)
Registrant - Anicare Pharmaceuticals Pvt. Ltd. (916837425)

Revised: 12/2020
Document Id: b6e18374-9a1d-804d-e053-2995a90a07c3
Set id: b6e17de9-16b6-2ce6-e053-2995a90a151d
Version: 1
Effective Time: 20201220
 
Anicare Pharmaceuticals Pvt. Ltd.