Sha-lem
FDA Label NDC 59862-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shalem Products, Inc. for the product Sha-lem (NDC 59862-100). 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 drug facts, active ingredients, purpose, uses, warnings, inactive ingredient, packaging, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Palmitic Acid, Stearic Acid, Oleic Acid, Bismuth Subcarbonate, Boric Acid
Purpose
Skin Protectant
Uses
Helps prevent and temporarily protects chafed, chapped, cracked or wind burned skin and lips. Temporary protection of minor cuts, scrapes, burns and sunburn. Use on most forms of skin irritations, rashes, non-poisonous insect bites.
Warnings
Skin Protectant For External Use Only
Inactive Ingredient
White wax
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