Drug Facts Box - Back Label

Drug Facts Box - Back Label
SPL v1
SPL
SPL Set ID cc5b466f-1932-42b8-9517-643af0c1084d
Route
TOPICAL
Published
Effective Date 2010-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (1.3 mL)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-10-13
Description

Dimethicone 1.3%

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Dimethicone 1.3%

Uses
For moisturizing and protecting the skin from drying effects
Warnings
  • For external use only.

Directions

Apply as needed

Package Label

cvs2.5.jpg

Active Ingredient

Dimethicone 1.3%

Inactive Ingredients



Avena Sativa (oat) Kernel Flour, Benzyl Alcohol, Cetyl Alcohol, Distearyldimonium Chloride, Glycerin, Isopropyl Palmitate, Petrolatum, Sodium Chloride, Methylparaben, Propylparaben, Water.

When Using This Product

Avoid contact with eyes. If contact occurs, rinse with water

Keep Out of Reach of Children

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

Stop Using This Product and Ask Doctor If

irritation or redness develops and lasts

Structured Label Content

Uses
For moisturizing and protecting the skin from drying effects
Purpose

Skin Protectant

Warnings
  • For external use only.

Directions

Apply as needed

Package Label

cvs2.5.jpg

Active Ingredient

Dimethicone 1.3%

Inactive Ingredients



Avena Sativa (oat) Kernel Flour, Benzyl Alcohol, Cetyl Alcohol, Distearyldimonium Chloride, Glycerin, Isopropyl Palmitate, Petrolatum, Sodium Chloride, Methylparaben, Propylparaben, Water.

When Using This Product (When using this product)

Avoid contact with eyes. If contact occurs, rinse with water

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

Stop Using This Product and Ask Doctor If (Stop using this product and ask doctor if)

irritation or redness develops and lasts

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:08.661333 · Updated: 2026-03-14T22:52:29.225907