Active Ingredient
DIMETHICONE 1.0%
Healthy Accents
FDA Label NDC 55316-315
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dza Brands Llc for the product Healthy Accents (NDC 55316-315). 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, warning, when using this product, stop using this product and ask a doctor if, keep out of reach of children, purpose, uses, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warning
FOR EXTERNAL USE ONLY.
When Using This Product
AVOID CONTACT WITH EYES, IF CONTACT OCCURS, RINSE EYE THROUGHLY WITH WATER.
Stop Using This Product And Ask A Doctor If
CONDITION WORSENS OR SYMPTOMS PERSIST FOR MORE THAN SEVEN DAYS OR OCCUR AGAIN WITHIN A FEW DAYS.
Keep Out Of Reach Of Children
IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Purpose
Skin Protectant
Uses
HELPS PREVENT AND TEMPORARILY PROTECTS CHAFED, CHAPPED OR CRACKED SKIN
Directions
APPLY AS NEEDED.
Inactive Ingredients
Water, White Petrolatum, Glycerin, Stearic Acid, Glycol Stearate, Helianthus Annuus (Sunflower) Seed Oil, Glycine Soja (Soybean) Sterols, Lecithin, Tocopheryl Acetate, Retinyl Palmitate, Fragrance, Urea, Collagen Amino Acids, Sodium Stearoyl Lactylate, Sodium PCA, Potassium Lactate, Lactic Acid, Cetyl Alcohol, Glyceryl Stearate, Magnesium Aluminum Silicate, Carbomer, Stearamide AMP, Ethylene Brassylate, Triethanolamine, Corn Oil, Disodium EDTA, Methylparaben, DMDM Hydantoin, BHT, Titanium Dioxide
Package Front And Back Labels
10 OZ Front and Back Labels: hac10.jpg
10oz Front And Back Labels (Hac10)
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