Ameriderm
FDA Label NDC 52410-8050

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shield Line Llc for the product Ameriderm (NDC 52410-8050). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

* Please review the disclaimer below.