Back Label - Drug Facts Box

Back Label - Drug Facts Box
SPL v1
SPL
SPL Set ID 3334f923-ed7d-4209-aad4-849d8d559569
Route
TOPICAL
Published
Effective Date 2010-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (1 mL)
Inactive Ingredients
Water Petrolatum Stearic Acid Glycol Stearate Sunflower Oil Soy Sterol Lecithin, Soybean .alpha.-tocopherol Acetate, D- Vitamin A Palmitate Urea Sodium Isostearoyl Lactylate Sodium Pyrrolidone Carboxylate Potassium Lactate Lactic Acid Cetyl Alcohol Glyceryl Monostearate Magnesium Aluminum Silicate Carbomer 934 Stearamidoethyl Diethylamine Ethylene Brassylate Trolamine Corn Oil Edetate Disodium Methylparaben Dmdm Hydantoin Butylated Hydroxytoluene Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-06-25

Description

DIMETHICONE 1.0%

Purpose

Skin Protectant


Medication Information

Purpose
Skin Protectant
Description

DIMETHICONE 1.0%

Uses
HELPS PREVENT AND TEMPORARILY PROTECTS CHAFED, CHAPPED OR CRACKED SKIN
Warning

FOR EXTERNAL USE ONLY.

Directions
APPLY AS NEEDED.
Active Ingredient

DIMETHICONE 1.0%

Inactive Ingredients

Water, White Petrolatum, Glycerin, Stearic Acid, Glycol Stearate, Helianthus Annuus (Sunflower) Seed Oil, Glycine Soja (Soybean) Sterols, Lecithin, Tocopheryl Acetate, Retinyl Palmitate, Fragrance, Urea, Collagen Amino Acids, Sodium Stearoyl Lactylate, Sodium PCA, Potassium Lactate, Lactic Acid, Cetyl Alcohol, Glyceryl Stearate, Magnesium Aluminum Silicate, Carbomer, Stearamide AMP, Ethylene Brassylate, Triethanolamine, Corn Oil, Disodium EDTA, Methylparaben, DMDM Hydantoin, BHT, Titanium Dioxide

When Using This Product

AVOID CONTACT WITH EYES, IF CONTACT OCCURS, RINSE EYE THROUGHLY WITH WATER.

Keep Out of Reach of Children

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

Package Front and Back Labels

10 OZ Front and Back Labels: hac10.jpg

Stop Using This Product and Ask A Doctor If

CONDITION WORSENS OR SYMPTOMS PERSIST FOR MORE THAN SEVEN DAYS OR OCCUR AGAIN WITHIN A FEW DAYS.


Structured Label Content

Uses
HELPS PREVENT AND TEMPORARILY PROTECTS CHAFED, CHAPPED OR CRACKED SKIN
Purpose
Skin Protectant
Warning (WARNING)

FOR EXTERNAL USE ONLY.

Directions
APPLY AS NEEDED.
Active Ingredient (ACTIVE INGREDIENT)

DIMETHICONE 1.0%

Inactive Ingredients

Water, White Petrolatum, Glycerin, Stearic Acid, Glycol Stearate, Helianthus Annuus (Sunflower) Seed Oil, Glycine Soja (Soybean) Sterols, Lecithin, Tocopheryl Acetate, Retinyl Palmitate, Fragrance, Urea, Collagen Amino Acids, Sodium Stearoyl Lactylate, Sodium PCA, Potassium Lactate, Lactic Acid, Cetyl Alcohol, Glyceryl Stearate, Magnesium Aluminum Silicate, Carbomer, Stearamide AMP, Ethylene Brassylate, Triethanolamine, Corn Oil, Disodium EDTA, Methylparaben, DMDM Hydantoin, BHT, Titanium Dioxide

When Using This Product (When using this product)

AVOID CONTACT WITH EYES, IF CONTACT OCCURS, RINSE EYE THROUGHLY 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.

Package Front and Back Labels

10 OZ Front and Back Labels: hac10.jpg

Stop Using This Product and Ask A Doctor If (STOP USING THIS PRODUCT AND ASK A DOCTOR IF)

CONDITION WORSENS OR SYMPTOMS PERSIST FOR MORE THAN SEVEN DAYS OR OCCUR AGAIN WITHIN A FEW DAYS.


Advanced Ingredient Data


Raw Label Data

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