Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID b93a9119-e910-4c5e-ba4d-cbdd11b1f32d
Route
TOPICAL
Published
Effective Date 2012-04-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (.02 mL)
Inactive Ingredients
Water Lanolin Cod Liver Oil Propylene Glycol High Density Polyethylene Sodium Polyacrylate (2500000 Mw) Cetyl Alcohol Yellow Wax Glyceryl Monostearate Medium-chain Triglycerides Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Sodium Laureth Sulfate Diazolidinyl Urea Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-04-04
Description

Active ingredient                 Purpose Dimethicone 2%...................Skin Protectant

Medication Information

Warnings and Precautions

Warnings

When using this product • Do not get into eyes. Stop use and ask doctor if: • Condition worsens • Symptoms last more than 7 days or clear up and occur again within a few days. Do not use on: Deep or puncture wounds • Animal bites • Serious burns.

Indications and Usage

Directions

Apply as needed.

Dosage and Administration

For external use only.

Description

Active ingredient                 Purpose Dimethicone 2%...................Skin Protectant

Section 50565-1

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients

Water, Lanolin Oil, Cod Liver Oil, Propylene Glycol, Polyethylene, Sodium Polyacrylate, Cetyl Alcohol, Beeswax, Glyceryl Stearate, Caprylic/Capric Triglyceride, Sodium Acrylate/Sodium AcryloyldimethylTaurate Copolymer, Sodium Laureth Sulfate, Diazolidinyl Urea, Methylparaben, Propylparaben, Fragrance.

Section 51945-4
Section 55105-1

Uses Helps to prevent and temporarily protect chafed, chapped, or cracked skin.

Section 55106-9


Active ingredient                 Purpose

Dimethicone 2%...................Skin Protectant





Structured Label Content

Indications and Usage (34067-9)

Directions

Apply as needed.

Dosage and Administration (34068-7)

For external use only.

Warnings and Precautions (34071-1)

Warnings

When using this product • Do not get into eyes. Stop use and ask doctor if: • Condition worsens • Symptoms last more than 7 days or clear up and occur again within a few days. Do not use on: Deep or puncture wounds • Animal bites • Serious burns.

Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients

Water, Lanolin Oil, Cod Liver Oil, Propylene Glycol, Polyethylene, Sodium Polyacrylate, Cetyl Alcohol, Beeswax, Glyceryl Stearate, Caprylic/Capric Triglyceride, Sodium Acrylate/Sodium AcryloyldimethylTaurate Copolymer, Sodium Laureth Sulfate, Diazolidinyl Urea, Methylparaben, Propylparaben, Fragrance.

Section 51945-4 (51945-4)
Section 55105-1 (55105-1)

Uses Helps to prevent and temporarily protect chafed, chapped, or cracked skin.

Section 55106-9 (55106-9)


Active ingredient                 Purpose

Dimethicone 2%...................Skin Protectant





Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:26.475854 · Updated: 2026-03-14T22:53:04.035717