Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 3df61336-2508-4a28-baa2-ef4645042b19
Route
TOPICAL
Published
Effective Date 2014-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (2 g)
Inactive Ingredients
Water Aloe Vera Leaf Centella Asiatica Fucus Vesiculosus Ginkgo Biloba Whole Shea Butter Caffeine Almond Oil Xanthan Gum Edetate Sodium Sambucus Nigra Flowering Top Jojoba Oil, Randomized Glycerin Green Tea Leaf Equisetum Arvense Branch Hydrolyzed Wheat Protein (enzymatic, 3000 Mw) Alpha-tocopherol Acetate Propylene Glycol Trolamine Dmdm Hydantoin D&c Orange No. 11 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-07-15
Description

Dimethicone 2%

Purpose

Skin protectant

Medication Information

Purpose

Skin protectant

Description

Dimethicone 2%

Use

■ helps prevent, temporarily protects and relieve chafed, chapped, or cracked skin

Warnings

For external use only

Directions

apply as needed

Do Not Use On

■ deep or puncture wounds ■ animal bites ■ serious burns

Product Label

Active Ingredient

Dimethicone 2%

Inactive Ingredients

Deionized Water, Aloe Vera (Aloe Barbadensis) Leaf Gel, Gotu Kola (Centella Asiatica) Extract, Seaweed (Fucus Vesiculosus) Extract, Ginkgo biloba, Shea (Butyrospermum Parkii) Butter, Cocoa (Theobroma Cacao) Butter, Caffeine, Sweet Almond (Prunus Amygdalus Dulcis) Oil, Xanthan Gum, Tetrasodium EDTA, Elderberry (Sambucus Nigra) Extract, Jojoba Esters, Glycerin, Green Tea (Camellia Sinensis) Leaf Extract, Horsetail (Equisetum Arvense) Extract, Hydrolyzed Wheat Proteins, Tocopheryl Acetate (Vitamin E), Acrylates Copolymer, Propylene Glycol, SD-Alcohol 40B, Triethanolamine, Fragrance, DMDM Hydantoin, Caramel Color, D&C Orange #4, FD&C Yellow #5

When Using This Product

■ do not get into eyes

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.

If Pregnant Or Breast Feeding

ask a health professional before use

Keep Out of Reach of Children

to avoid accidental poisoning, in case of accidental ingestion contact a doctor or Poison Control Center immediately.

Structured Label Content

Use

■ helps prevent, temporarily protects and relieve chafed, chapped, or cracked skin

Purpose

Skin protectant

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

Product Label

Active Ingredient

Dimethicone 2%

Inactive Ingredients

Deionized Water, Aloe Vera (Aloe Barbadensis) Leaf Gel, Gotu Kola (Centella Asiatica) Extract, Seaweed (Fucus Vesiculosus) Extract, Ginkgo biloba, Shea (Butyrospermum Parkii) Butter, Cocoa (Theobroma Cacao) Butter, Caffeine, Sweet Almond (Prunus Amygdalus Dulcis) Oil, Xanthan Gum, Tetrasodium EDTA, Elderberry (Sambucus Nigra) Extract, Jojoba Esters, Glycerin, Green Tea (Camellia Sinensis) Leaf Extract, Horsetail (Equisetum Arvense) Extract, Hydrolyzed Wheat Proteins, Tocopheryl Acetate (Vitamin E), Acrylates Copolymer, Propylene Glycol, SD-Alcohol 40B, Triethanolamine, Fragrance, DMDM Hydantoin, Caramel Color, D&C Orange #4, FD&C Yellow #5

When Using This Product (When using this product)

■ do not get into 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.

If Pregnant Or Breast Feeding (If pregnant or breast feeding)

ask a health professional before use

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

to avoid accidental poisoning, in case of accidental ingestion contact a doctor or Poison Control Center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:49.351608 · Updated: 2026-03-14T22:53:46.796959