Daily Moisturizing with Colloidal Oats: Package Insert and Label Information

DAILY MOISTURIZING WITH COLLOIDAL OATS- cetyl alcohol 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%

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
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETYL ALCOHOL (CETYL ALCOHOL) CETYL ALCOHOL 80 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
AVENA SATIVA FLOWERING TOP
STEARETH-20 METHACRYLATE
SODIUM CHLORIDE NA-22
WATER
.ALPHA.-(.ALPHA.-AMINOPROPYL)BENZYL ALCOHOL
GLYCERIN
DISTEARYLDIMONIUM CHLORIDE
SHEA BUTTER
PETROLATUM
ISOPROPYL PALMITATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50154-011-51 354 mL in 1 BOTTLE None
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 Operations
Lantern Enterprises Ltd. 004005196 manufacture (50154-011)

Revised: 05/2016 Lantern Enterprises Ltd.

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