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

Description

DIMETHICONE 1.3%

Purpose

SKIN PROTECTANT


Medication Information

Purpose

SKIN PROTECTANT

Description

DIMETHICONE 1.3%

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

Warnings

FOR EXTERNAL USE ONLY.

Directions

APPLY AS NEEDED.

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

Active Ingredient

DIMETHICONE 1.3%

Inactive Ingredients

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

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

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

Purpose (PURPOSE)

SKIN PROTECTANT

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

Directions (DIRECTIONS)

APPLY AS NEEDED.

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

Active Ingredient (ACTIVE INGREDIENT)

DIMETHICONE 1.3%

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.

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

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