AMERIDERM DERMAFIX- lanolin ointment

AmeriDerm by

Drug Labeling and Warnings

AmeriDerm by is a Otc medication manufactured, distributed, or labeled by Shield Line LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

AMERIDERM  DERMAFIX
lanolin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52410-8050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	22 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN OIL (UNII: 8470G57WFM)
ETHYLPARABEN (UNII: 14255EXE39)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
PETROLATUM (UNII: 4T6H12BN9U)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
WATER (UNII: 059QF0KO0R)
ZINC CHLORIDE (UNII: 86Q357L16B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52410-8050-3	113 g in 1 JAR; Type 0: Not a Combination Product	02/01/2015
2	NDC: 52410-8050-2	113 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/01/2015

Labeler - Shield Line LLC (078518916)