Dermatitis Face Balm Ointment
FDA Label NDC 61328-121

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Skinfix, Inc. for the product Dermatitis Face Balm (NDC 61328-121). 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 ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Colloidal Oatmeal 5%

Purpose

Skin protectant

Uses

Temporarily protects and helps relieve minor skin irritations and itching due to eczema, rash and dermatitis.

Warnings

For external use only.

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 swallowed get medical help or contact a Poison Control Center right away.

Directions

Apply to affected areas as needed.

Other Information

STORE AT 65-75°F. MAY STAIN FABRICS. FOR ADULTS AND CHILDREN TWO YEARS OF AGE AND OLDER.

Inactive Ingredients

Allantoin, Beeswax, butyrospermum parkii (shea) butter, glycine soja (soybean) oil, paraffin wax, petrolatum, prunus amygdalus dulcis (sweet almond) oil, simmondsia chinensis (jojoba) seed oil, tocopherol.

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