Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 76ac2257-a54c-4c6a-8a30-b5f89e0bbc42
Route
TOPICAL
Published
Effective Date 2013-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (1 g)
Inactive Ingredients
Methylisothiazolinone Mineral Oil Petrolatum Trolamine .alpha.-tocopherol Acetate Water Avena Sativa Flowering Top Benzyl Alcohol Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Fd&c Blue No. 1 Fd&c Yellow No. 5 Fd&c Yellow No. 6 Glycerin Methylchloroisothiazolinone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-01-31

Description

Dimethicone 1%

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

Dimethicone 1%

Uses

■Helps prevent and temporarily protects chafed, chapped, or cracked skin

■Helps prevent and protect from the drying effects of wind and cold weather

Warnings

For external use only

Directions

Apply as needed

Do Not Use On

■Deep or puncture wounds

■Animal bites

■Serious burns

Product Label

Active Ingredient

Dimethicone 1%

Inactive Ingredients

avena sativa (oat) kernel flour, benzyl alcohol, carbomer, ceteareth-20, cetrimonium chloride, cetearyl alcohol, FD&C blue no.1, FD&C yellow no.5, FD&C yellow no.6, glycerin, methylchloroisothiazolinone, methylisothiazolinone, mineral oil, petrolatum, p glycol, triethanolamine, tocopheryl acetate, water

When Using This Product

■Do not get into eyes

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

If swallowed, get medical help or contact a Poison Control Center immediately.


Structured Label Content

Uses

■Helps prevent and temporarily protects chafed, chapped, or cracked skin

■Helps prevent and protect from the drying effects of wind and cold weather

Purpose

Skin protectant

Warnings

For external use only

Directions

Apply as needed

Do Not Use On (Do not use on)

■Deep or puncture wounds

■Animal bites

■Serious burns

Product Label

Active Ingredient

Dimethicone 1%

Inactive Ingredients (Inactive ingredients)

avena sativa (oat) kernel flour, benzyl alcohol, carbomer, ceteareth-20, cetrimonium chloride, cetearyl alcohol, FD&C blue no.1, FD&C yellow no.5, FD&C yellow no.6, glycerin, methylchloroisothiazolinone, methylisothiazolinone, mineral oil, petrolatum, p glycol, triethanolamine, tocopheryl acetate, water

When Using This Product (When using this product)

■Do not get into eyes

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)

If swallowed, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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