Drug Facts Box - Back Label

Drug Facts Box - Back Label
SPL v2
SPL
SPL Set ID 3e21f959-aab5-43f0-af1b-aee0c3bb8995
Route
TOPICAL
Published
Effective Date 2016-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (13 mg)
Inactive Ingredients
Oatmeal Benzyl Alcohol Cetyl Alcohol Distearyldimonium Chloride Glycerin Isopropyl Palmitate Petrolatum Sodium Chloride Methylparaben Propylparaben Dmdm Hydantoin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-03-08

Description

Dimethicone 1.3%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Dimethicone 1.3%

Uses

helps prevent and temporarily protects chafed, chapped or cracked skin.

Warnings

For external use only.

Directions

Apply as needed

Label Copy

Active Ingredient

Dimethicone 1.3%

Inactive Ingredients

Water (Aqua), Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl palmitate,  Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Sodium Chloride,  DMDM Hydantoin, Methylparaben, Propylparaben.

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 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

Warnings

For external use only.

Directions

Apply as needed

Label Copy

Active Ingredient

Dimethicone 1.3%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl palmitate,  Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Sodium Chloride,  DMDM Hydantoin, Methylparaben, Propylparaben.

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 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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