Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0b394675-00de-4d9c-bb31-dc79218de647
Route
TOPICAL
Published
Effective Date 2018-03-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (50 mg) Menthol (5 mg)
Inactive Ingredients
Water Cetostearyl Alcohol Cetyl Alcohol Polysorbate 60 Distearyldimonium Chloride Glycerin Stearamidopropyl Pg-dimonium Chloride Phosphate Petrolatum Aloe Vera Leaf Stearyl Alcohol Steareth-2 Steareth-21 .alpha.-tocopherol Acetate, Dl- Edetate Sodium Benzyl Alcohol Iodopropynyl Butylcarbamate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-03-28
Description

Dimethicone 5.0%, Menthol 0.5%

Purpose

Skin Protectant, Anti-itch

Medication Information

Purpose

Skin Protectant, Anti-itch

Description

Dimethicone 5.0%, Menthol 0.5%

Uses
  • temporarily protects and helps relieve chapped or cracked skin.
  • temporarily relieves itching associated with: minor skin irritations, minor burns, rashes due to poison ivy, oak and sumac
  • insect bites
  • sunburn
Warnings

For external use only

Directions

apply as needed

Label Copy

Do Not Use On
  • deep or puncture wournds
  • animal bites
  • serious burns
Other Information

store at room temperature.

Active Ingredients

Dimethicone 5.0%, Menthol 0.5%

Inactive Ingredients

Water (Aqua), Cetearyl Alcohol, Cetyl Alcohol, Polysorbate 60, Distearyldimonium Chloride, Glycerin, Stearamidopropyl PG-Dimonium Chloride Phosphate, Petrolatum, Aloe Barbadensis Leaf Juice, Stearyl Alcohol, Steareth-2, Steareth-21, Tocopheryl Acetate, Tetrasodium EDTA, Benzyl Alcohol, Iodopropynyl Butylcarbamate, Fragrance (Parfum).

Questions Or Comments?

1-866-695-3030

When Using This Product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness, irritation, swelling or pain persists or increases
Keep Out of Reach of Children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Structured Label Content

Uses
  • temporarily protects and helps relieve chapped or cracked skin.
  • temporarily relieves itching associated with: minor skin irritations, minor burns, rashes due to poison ivy, oak and sumac
  • insect bites
  • sunburn
Purpose

Skin Protectant, Anti-itch

Warnings

For external use only

Directions

apply as needed

Label Copy

Do Not Use On (Do not use on)
  • deep or puncture wournds
  • animal bites
  • serious burns
Other Information (Other information)

store at room temperature.

Active Ingredients (Active ingredients)

Dimethicone 5.0%, Menthol 0.5%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Cetearyl Alcohol, Cetyl Alcohol, Polysorbate 60, Distearyldimonium Chloride, Glycerin, Stearamidopropyl PG-Dimonium Chloride Phosphate, Petrolatum, Aloe Barbadensis Leaf Juice, Stearyl Alcohol, Steareth-2, Steareth-21, Tocopheryl Acetate, Tetrasodium EDTA, Benzyl Alcohol, Iodopropynyl Butylcarbamate, Fragrance (Parfum).

Questions Or Comments? (Questions or comments?)

1-866-695-3030

When Using This Product (When using this product)

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness, irritation, swelling or pain persists or increases
Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:32.931181 · Updated: 2026-03-14T22:55:05.352338