DAILY MOISTURIZING WITH COLLOIDAL OATS- cetyl alcohol 0.80% lotion 
Lantern Enterprises Ltd.

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.

----------

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

  • For external use only - hands
  • Stop use and contact a doctor if condition worsens and does not improve in seven days.
  • Avoid contact with eyes. In case of contact with eyes, flush thoroughly with water

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:50154-011
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:50154-011-51354 mL in 1 BOTTLE; Type 0: Not a Combination Product05/13/201610/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/13/201610/31/2021
Labeler - Lantern Enterprises Ltd. (004005196)
Establishment
NameAddressID/FEIBusiness Operations
Shenzhen Lantern Science Co.,Ltd.421222423manufacture(50154-011)

Revised: 10/2021
Document Id: cf60a540-3a3f-1a52-e053-2995a90aef57
Set id: 32c0fcf5-a015-6dc7-e054-00144ff88e88
Version: 2
Effective Time: 20211027
 
Lantern Enterprises Ltd.