The following Structured Product Label (SPL) was submitted to the FDA by Conopco Inc. D/b/a Unilever for the product Vaseline Intensive Care (NDC 64942-1048). 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 warnings, otc - active ingredient, inactive ingredient, package label.principal display panel, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Warnings
WARNING: FOR EXTERNAL USE ONLY. AVOID EYE CONTACT. RINSE WITH WATER TO REMOVE. IF RASH OR IRRITATION DEVELOPS, STOP USE AND ASK A DOCTOR. KEEP AWAY FROM CHILDREN. IF SWALLOWED, CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Otc - Active Ingredient
ACTIVE INGREDIENTS: OCTINOXATE (7.5%)OXYBENZONE (3.0%) OCTISALATE (1.0%)
Inactive Ingredient
Water, Stearic Acid, Glycerin, Isopropyl Palmitate, Aloe Barbadensis (Aloe Vera) Leaf Juice, Euterpe Oleracea (Acai) Fruit Extract, Camellia Sinensis (Green Tea) Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract, Tocopheryl Acetate, Retinyl Palmitate, Dimethicone, Potassium Lactate, Lactic Acid, Collagen Amino Acids, Glycine Soja (Soybean) Sterol, Lecithin, Petrolatum, Helianthus Annuus (Sunflower) Seed Oil or Glycine Soja (Soybean) Oil, Sodium PCA, Sodium Stearoyl-2-Lactylate, Urea, Mineral Water, Glyceryl Stearate, Carbomer, Cetyl Alcohol, Magnesium Aluminum Silicate, Fragrance, Potassium Hydroxide, DMDM Hydantoin, Disodium EDTA, Methylparaben, Propylparaben, Titanium Dioxide.
Package Label.Principal Display Panel
PDP 20.3 oz front
PDP 20.3 oz back
Otc - Questions
Questions section
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