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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETYL ALCOHOL (UNII: 936JST6JCN) (CETYL ALCOHOL - UNII:936JST6JCN)	CETYL ALCOHOL	80 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50306-010-51	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		05/16/2016

Labeler - Shanghai Lantern Cosmetic Co (421252043)

Name	Address	ID/FEI	Business Operations
Establishment
Shanghai Lantern Cosmetic Co		421252043	manufacture(50306-010)