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AmeriDerm DermaFix

Medically reviewed on October 13, 2016

Dosage form: ointment
Ingredients: LANOLIN 22g in 100g
Labeler: Shield Line LLC
NDC Code: 52410-8050

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

Active Ingredient

Lanolin 22%

Purpose

Skin Protectant

Uses

■ Helps prevent and temporarily protects chafed, chapped, or cracked skin

■ Temporarily protects minor: ■ cuts ■ cuts ■ scrapes ■ burns

Warnings

FOR EXTERNAL USE ONLY

When using this product

■ Avoid contact with eyes ■ If eye contact occurs, flush with water

Stop use and ask a doctor if

■ condition worsens

■ symptoms last more than seven days or clear up and occur again within several days

Do not use on

■ deep or puncture wounds

■ lacerations ■ animal bites

■ serious burns

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply as needed to clean skin twice daily or more often if necessary ■ For children under 6 months ask a doctor

Inactive Ingredients

Aluminum Hydroxide, Alpha Tocopherol Acetate (Vitamin E), Calcium Carbonate, Cholecalciferol (Vitamin D3), Citric Acid, Corn Oil, Ethylparaben, Lanolin Alcohols, Magnesium Hydroxide, Methylparaben, Sodium Chloride, Sodium Laureth Sulfate, Petrolatum, Vitamin A Palmitate, Water, Zinc Chloride

Product Label

AMERIDERM  DERMAFIX
lanolin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-8050
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANOLIN (LANOLIN) LANOLIN22 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE 
.ALPHA.-TOCOPHEROL ACETATE 
CALCIUM CARBONATE 
CHOLECALCIFEROL 
CITRIC ACID MONOHYDRATE 
CORN OIL 
ETHYLPARABEN 
LANOLIN ALCOHOLS 
MAGNESIUM HYDROXIDE 
METHYLPARABEN 
SODIUM CHLORIDE 
SODIUM LAURETH SULFATE 
PETROLATUM 
VITAMIN A PALMITATE 
WATER 
ZINC CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:52410-8050-3113 g in 1 JAR
2NDC:52410-8050-2113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/01/2015
Labeler - Shield Line LLC (078518916)

 
Shield Line LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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