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All Day Skin Relief with Colloidal Oats

Dosage form: lotion
Ingredients: CETYL ALCOHOL 80mg in 100mL
Labeler: Lantern Enterprises Ltd.
NDC Code: 50154-012

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

ALL DAY SKIN RELIEF WITH COLLOIDAL OATS 
cetyl alcohol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50154-012
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYL ALCOHOL (CETYL ALCOHOL) CETYL ALCOHOL80 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage Description
1NDC:50154-012-50354 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/13/2016
Labeler - Lantern Enterprises Ltd. (004005196)
Establishment
NameAddressID/FEIOperations
Lantern Enterprises Ltd.004005196manufacture(50154-012)

Revised: 05/2016
 
Lantern Enterprises Ltd.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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