drug facts

drug facts
SPL v1
SPL
SPL Set ID e2dac4b3-a0ba-4c3f-8455-abffc10c847b
Route
topical
Published
Effective Date 2011-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (1.3 g)
Inactive Ingredients
water glycerin distearyldimonium chloride petrolatum isopropyl palmitate cetyl alcohol oatmeal benzyl alcohol sodium chloride dmdm hydantoin methylparaben propylparaben

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2011-11-03
Purpose

SKIN PROTECTANT

Description

DIMETHICONE 1.3%

Medication Information

Warnings

FOR EXTERNAL USE ONLY.

Uses
TEMPORARILY PROTECTS AND HELPS RELIEVE CHAFED, CHAPPED OR CRACKED SKIN.

Purpose

SKIN PROTECTANT

Directions

APPLY AS NEEDED.

Inactive Ingredients

WATER, GLYCERIN, DISTEARYLDIMONIUM CHLORIDE, PETROLATUM, ISOPROPYL MYRISTATE, CETYL ALCOHOL, AVENA SATIVA (OAT) KERNEL FLOUR, BENZYL ALCOHOL, SODIUM CHLORIDE, DMDM HYDANTOIN, METHYLPARABEN, PROPYLPARABEN.

Description

DIMETHICONE 1.3%

Do Not Use
  • ON DEEP PUNCTURE WOUNDS
  • ON ANIMAL BITES
  • ON SERIOUS BURNS

Active Ingredient

DIMETHICONE 1.3%

Front and Back Labels

When Using This Product

DO NOT GET INTO EYES.  SHOULD THIS OCCUR, RINSE WITH WATER.

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.

Keep Out of Reach of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Structured Label Content

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

Uses (USES)
TEMPORARILY PROTECTS AND HELPS RELIEVE CHAFED, CHAPPED OR CRACKED SKIN.

Purpose (PURPOSE)

SKIN PROTECTANT

Directions (DIRECTIONS)

APPLY AS NEEDED.

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER, GLYCERIN, DISTEARYLDIMONIUM CHLORIDE, PETROLATUM, ISOPROPYL MYRISTATE, CETYL ALCOHOL, AVENA SATIVA (OAT) KERNEL FLOUR, BENZYL ALCOHOL, SODIUM CHLORIDE, DMDM HYDANTOIN, METHYLPARABEN, PROPYLPARABEN.

Do Not Use (DO NOT USE)
  • ON DEEP PUNCTURE WOUNDS
  • ON ANIMAL BITES
  • ON SERIOUS BURNS

Active Ingredient (ACTIVE INGREDIENT)

DIMETHICONE 1.3%

Front and Back Labels (FRONT AND BACK LABELS)

When Using This Product (WHEN USING THIS PRODUCT)

DO NOT GET INTO EYES.  SHOULD THIS OCCUR, RINSE WITH WATER.

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.

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: 2026-02-15T11:55:21.699396 · Updated: 2026-03-14T22:52:54.626056