DAILY MOISTURIZING WITH COLLOIDAL OATS- cetyl alcohol 0.80% lotion 
Shanghai Lantern Cosmetic Co

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ETYL ALCOHOL 0.80%

PURPOSE

Skin Protectant

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

INDICATION AND USAGE

Relieves dry, itchy skin and provides hydration.

DIRECTIONS

Adults and children over two years of age. Apply up to 3-4 times a day.

Chilldren under two years of age, consult a physician.

WARNING

INACTIVE INGREDIENTS

WATER

GLYCERIN

DISTEARYLDIMONIUM CHLORIDE

PETROLATUM

ISOPROPYL PALMITATE

AVENA SATIVA (OAT) KERNEL FLOUR

BENZYL ALCOHOL

AVENA SATIVA (OAT) KERNEL OIL

STEARETH-20

AVENA SATIVA (OAT) KERNEL EXTRACT

BUTYROSPERMUM PARKII (SHEA BUTTER)

SODIUM CHLORIDE

LABEL

DAILY MOISTURIZING WITH COLLOIDAL OATS 
cetyl alcohol 0.80% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50306-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYL ALCOHOL (UNII: 936JST6JCN) (CETYL ALCOHOL - UNII:936JST6JCN) CETYL ALCOHOL80 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F)  
STEARETH-20 METHACRYLATE (UNII: A268NZ57NB)  
SODIUM CHLORIDE NA-22 (UNII: VMP9781061)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-(.ALPHA.-AMINOPROPYL)BENZYL ALCOHOL (UNII: S8TT5K3C8Y)  
GLYCERIN (UNII: PDC6A3C0OX)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
SHEA BUTTER (UNII: K49155WL9Y)  
PETROLATUM (UNII: 4T6H12BN9U)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50306-010-51354 mL in 1 BOTTLE; Type 0: Not a Combination Product05/16/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/16/2016
Labeler - Shanghai Lantern Cosmetic Co (421252043)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai Lantern Cosmetic Co421252043manufacture(50306-010)

Revised: 5/2016
Document Id: 32f88ea4-4cf8-05c7-e054-00144ff88e88
Set id: 32f88f07-4fa5-4395-e054-00144ff8d46c
Version: 1
Effective Time: 20160516
 
Shanghai Lantern Cosmetic Co