DAILY MOISTURIZING WITH COLLOIDAL OATS- cetyl alcohol 0.80% lotion

Daily Moisturizing with Colloidal Oats by

Drug Labeling and Warnings

Daily Moisturizing with Colloidal Oats by is a Otc medication manufactured, distributed, or labeled by Lantern Enterprises Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ETYL ALCOHOL 0.80%

PURPOSE

Skin Protectant

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

INDICATION AND USAGE

Relieves dry, itchy skin and provides hydration.

DOSAGE & ADMINISTRATION

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.

WARNINGS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DAILY MOISTURIZING WITH COLLOIDAL OATS 
cetyl alcohol 0.80% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50154-011
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50154-011-51	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/13/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/13/2016

Labeler - Lantern Enterprises Ltd. (004005196)

Establishment
Name	Address	ID/FEI	Business Operations
Lantern Enterprises Ltd.		004005196	manufacture(50154-011)