Vaseline
FDA Label NDC 64942-1867

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 64942-1867). 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 description, drug facts, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredient
Colloidal Oatmeal (1%)

Purpose

Skin Protectant

Uses

temporarily protects and helps relieve minor skin irritation and itching due to: eczema

Warnings

For external use only
When using this product do not get into eyes. If contact occurs, rinse thoroughly with water.
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 - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults, adolescents, and children over 6 months of age: Apply to affected area as needed

Inactive Ingredients

Water (Eau), Petrolatum, Glycerin, Stearic Acid, Glycol Stearate, Isopropyl Palmitate, Dimethicone, Triethanolamine, Glyceryl Stearate, Isopropyl Myristate, Cetyl Alcohol, Butyrospermum Parkii (Shea) Butter, Phenoxyethanol, Methylparaben, Magnesium Aluminum Silicate, Carbomer, Propylparaben, Stearamide AMP, Disodium EDTA, Hydroxystearic Acid.

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