3760752a-1d84-5d45-e054-00144ff88e88

SPL v2
SPL
SPL Set ID 3760752a-1d84-5d45-e054-00144ff88e88
Route
topical
Published
Effective Date 2016-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (10 mg)
Inactive Ingredients
alpha-tocopherol acetate peppermint oil styrene tribehenin aloe vera leaf yellow wax 1-butene ethylene c18-36 acid triglyceride eucalyptus oil ginkgo levomenol medium-chain triglycerides menthyl lactate, (-)- methylparaben mineral oil petrolatum propylene propylparaben tea tree oil

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2016-07-01
Purpose

Skin Protectant

Description

Dimethicone 1%

Medication Information

Warnings

For external use only.

Uses

Temporarily protects and helps relieve chapped or cracked skin. Helps protect from the druing effects of wind and cold weather,

Purpose

Skin Protectant

Directions

Apply liberally as needed before athletic activity or to areas of repetitive friction/rubbing

Dosage Forms and Strengths

Distributed by MedZone Products LLC

Lenexa, Kansas 66215

All rights reserved

Other Information

Store at room temperature. Avoid excessive heat.

Inactive Ingredients

Aloe Vera Leaf, Alpha-Tocopheryl Acetate, 1-Butene, C18-36 Acid Triglyceride, Ethylene, Eucalyptus Oil, Ginkgo, Levomenol, Medium-Chain Triglycerides, Menthyl Lactate, Methylparaben, Mineral oil, Peppermint Oil, Petrolatum, Propylene, Propylparaben, Styrene, Tea Tree Oil, Tribehenin, Yellow Wax

Description

Dimethicone 1%

Questions?

Toll-Free 866-MEDZONE (866-633-9663)

www.medzonecorp.com [email protected]

Section 51945-4

Do Not Use On:
  • deep or puncture wounds
  • serious burns
  • animal bites
Active Ingredient

Dimethicone 1%

When Using This Product

  • do not get into eyes.
Keep Out of Reach of Chlidren

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

Stop Use and Ask A Physician If

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Structured Label Content

Warnings

For external use only.

Uses

Temporarily protects and helps relieve chapped or cracked skin. Helps protect from the druing effects of wind and cold weather,

Purpose

Skin Protectant

Directions

Apply liberally as needed before athletic activity or to areas of repetitive friction/rubbing

Dosage Forms and Strengths (34069-5)

Distributed by MedZone Products LLC

Lenexa, Kansas 66215

All rights reserved

Other Information

Store at room temperature. Avoid excessive heat.

Inactive Ingredients

Aloe Vera Leaf, Alpha-Tocopheryl Acetate, 1-Butene, C18-36 Acid Triglyceride, Ethylene, Eucalyptus Oil, Ginkgo, Levomenol, Medium-Chain Triglycerides, Menthyl Lactate, Methylparaben, Mineral oil, Peppermint Oil, Petrolatum, Propylene, Propylparaben, Styrene, Tea Tree Oil, Tribehenin, Yellow Wax

Questions?

Toll-Free 866-MEDZONE (866-633-9663)

www.medzonecorp.com [email protected]

Section 51945-4 (51945-4)

Do Not Use On: (Do not use on:)
  • deep or puncture wounds
  • serious burns
  • animal bites
Active Ingredient

Dimethicone 1%

When Using This Product (When using this product)

  • do not get into eyes.
Keep Out of Reach of Chlidren (Keep out of reach of chlidren)

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

Stop Use and Ask A Physician If (Stop use and ask a physician if)

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:30.908828 · Updated: 2026-03-14T22:55:01.972489