Skinfix - Dermatitis Face Balm

Skinfix - Dermatitis Face Balm
SPL v6
SPL
SPL Set ID 86d2db7d-f1d4-4bca-aba4-d4c96b83c1a6
Route
TOPICAL
Published
Effective Date 2022-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (5 g)
Inactive Ingredients
Allantoin Yellow Wax Shea Butter Soybean Oil Paraffin Petrolatum Almond Oil Jojoba Oil Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-03
Description

Colloidal Oatmeal 5%

Purpose

Skin protectant

Medication Information

Purpose

Skin protectant

Description

Colloidal Oatmeal 5%

Uses

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

Section 50565-1

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

Section 51945-4

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.
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.

Active Ingredients

Colloidal Oatmeal 5%

Inactive Ingredients

Petrolatum, Glycine Soja (Soybean) Oil, Butyrospermum Parkii (Shea) Butter, Simmondsia Chinensis (Jojoba) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax, Paraffin, Allantoin, Tocopherol.

Structured Label Content

Uses

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

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Purpose

Skin protectant

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.
Directions

Apply to affected areas as needed.

Other Information (OTHER INFORMATION)

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

Active Ingredients

Colloidal Oatmeal 5%

Inactive Ingredients

Petrolatum, Glycine Soja (Soybean) Oil, Butyrospermum Parkii (Shea) Butter, Simmondsia Chinensis (Jojoba) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax, Paraffin, Allantoin, Tocopherol.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:05.851074 · Updated: 2026-03-14T23:06:25.914429