Label: AMERIDERM DERMAFIX- lanolin ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 52410-8050-2, 52410-8050-3 - Packager: Shield Line LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated October 13, 2016
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- Active Ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Do not use on
- Keep out of reach of children
- Directions
- Inactive Ingredients
- Product Label
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INGREDIENTS AND APPEARANCE
AMERIDERM DERMAFIX
lanolin ointmentProduct 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)