Otc - Active Ingredient
Active ingredient
Dimethicone (1%)
Vaseline
FDA Label NDC 64942-1038
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Conopco Inc. D/b/a Unilever for the product Vaseline (NDC 64942-1038). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - do not use, otc - 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
Otc - Purpose
Purpose
skin protectant
Indications & Usage
Uses
● temporarily protects and helps relieve chapped or cracked skin● helps protect from the drying effects of wind and cold weather
Warnings
Warnings
For External Use Only
Otc - When Using
When using this product do not get into eyes.
Otc - Stop Use
Stop use and ask a doctor if ● condition worsens ● symptoms last more than 7 days or clear up and occur again within a few days.
Otc - Do Not Use
Do not use on ● deep or puncture wounds ● animal bites ● serious burns
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
apply as needed
Inactive Ingredient
Inactive ingredients
Water, Glycerin, Isopropyl Palmitate, Distearyldimonium Chloride, Cetyl Alcohol, Mineral Oil, Steareth-21, Borago Officinalis Seed Oil, Glycine Soja (Soybean) Sterol, Petrolatum, Tocopheryl Acetate, Stearic Acid, Lecithin, Tapioca Starch, Stearyl Stearate, Sodium Chloride, Linoleic Acid, Linolenic Acid, Ethylene Brassylate, Methylparaben, Propylparaben, DMDM Hydantoin, Titanium Dioxide.
Otc - Questions
QUESTIONS & COMMENTS? Call 1-800-457-7084
Pdp 6.8 Fl. Oz.
Vaseline Intensive Care Clinical Fragrance Free (Vaselineintensivecareclinicalfragrancefree)
6.8 Fl. Oz. Carton
Vaseline Intensive Care Clinical Fragrance Free Carton (Vaselineintensivecareclinicalfragrancefreectn)
* Please review the disclaimer below.
