SPL v1
SPL
SPL Set ID 3ba3d3b3-ab13-ea80-e063-6394a90ad459
Route
TOPICAL
Published
Effective Date 2025-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone, Unspecified (1.5 g)
Inactive Ingredients
Carbomer Homopolymer, Unspecified Type Corn Oil Pyridoxine Hcl Fd&c Blue No. 1 Fd&c Yellow No. 6 Cholecalciferol Stearic Acid Peg-100 Stearate Olive Oil Niacinamide Lemon Oil, Cold Pressed Orange Oil, Cold Pressed Vitamin A Palmitate Cetearyl Alcohol Glycerin Glyceryl Monostearate Canola Oil Lavender Oil Fd&c Red No. 40 Ethylhexylglycerin Sodium Hydroxide Water Edetate Disodium Aloe Vera Leaf Phenoxyethanol Propylene Glycol .alpha.-tocopherol Acetate

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-15
Description

Dimethicone 1.5%

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Dimethicone 1.5%

Uses

Uses

  • Temporarily protects and helps relieve chafed, chapped or cracked skin
  • Helps protect from the drying effects of wind and cold weather
Section 51945-4

Warnings

Warnings

For external use only

Directions

Apply as needed

Do Not Use On

Do not use on deep or puncture wounds, animal bites, serious burns

Active Ingredient

Dimethicone 1.5%

Inactive Ingredients

Water, Propylene Glycol, Cetearyl Alcohol, Glycerin, Glyceryl Monostearate, Stearic Acid, PEG-100 Stearate, Carbomer, Olive Oil, Corn Oil, Canola Oil, Niacinamide, .Alpha.-Tocopherol Acetate, Vitamin A Palmitate, Cholecalciferol, Edetate Disodium, Aloe Vera Extract, Citrus Medica Limonum (Lemon) Peel Oil, Orange Oil, Cold Pressed, Lavender Oil, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol, Pyridoxine HCl, Fragrance, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6

When Using This Product

When using this product do not use near or get into the eyes.

Stop Use and Ask A Doctor If

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
Keep Out of Reach of Children

Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.

Structured Label Content

Uses

Uses

  • Temporarily protects and helps relieve chafed, chapped or cracked skin
  • Helps protect from the drying effects of wind and cold weather
Section 51945-4 (51945-4)

Purpose

Skin Protectant

Warnings

Warnings

For external use only

Directions

Apply as needed

Do Not Use On (Do not use on)

Do not use on deep or puncture wounds, animal bites, serious burns

Active Ingredient

Dimethicone 1.5%

Inactive Ingredients

Water, Propylene Glycol, Cetearyl Alcohol, Glycerin, Glyceryl Monostearate, Stearic Acid, PEG-100 Stearate, Carbomer, Olive Oil, Corn Oil, Canola Oil, Niacinamide, .Alpha.-Tocopherol Acetate, Vitamin A Palmitate, Cholecalciferol, Edetate Disodium, Aloe Vera Extract, Citrus Medica Limonum (Lemon) Peel Oil, Orange Oil, Cold Pressed, Lavender Oil, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol, Pyridoxine HCl, Fragrance, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6

When Using This Product (When using this product)

When using this product do not use near or get into the eyes.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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
Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:00.158557 · Updated: 2026-03-14T23:10:09.220745