Drug Facts 62654-142

Drug Facts 62654-142
SPL v6
SPL
SPL Set ID bfa07058-7a20-4b9f-bad1-4b9fb5c037e0
Route
TOPICAL
Published
Effective Date 2011-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (1.5 g)
Inactive Ingredients
Water Isopropyl Palmitate Cetostearyl Alcohol Stearic Acid Polyoxyl 20 Cetostearyl Ether Peg-100 Stearate Cyclomethicone 5 Tocopherol Corn Oil Vitamin A Palmitate Cholecalciferol Oat Bran Glycerin Allantoin Phenoxyethanol Dmdm Hydantoin Iodopropynyl Butylcarbamate Polyethylene Glycol 400 Aluminum Starch Octenylsuccinate Isohexadecane Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-06-01

Description

Active Ingredients Dimethicone 1.5% (w/w)


Medication Information

Warnings and Precautions

Warnings

For External Use Only



Indications and Usage

Uses

Temporarily protects and helps relieve chapped or cracked skin

Beneficial for face, hands, body and legs

Dosage and Administration

Directions

Apply cream liberally as needed

Description

Active Ingredients Dimethicone 1.5% (w/w)

Section 44425-7

Other Information

Protect from freezing.

Avoid excessive heat

Section 50565-1

Keep out of reach of children

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

Section 50566-9

Stop use and ask a doctor if

condition worsens

symptoms last for more than 7 days or clear up and occur within a few days

Section 50567-7

When using this product

do not get into eyes

Section 50570-1

Do not use

on deep or puncture wounds

on animal bites

on serious burns

Section 51727-6

Inactive Ingredients

Purified Water, Theobroma Grandiflorum Seed (Cupuacu Butter), Isopropyl Palmitate, Cetearyl Alcohol, Stearic Acid, Ceteareth 20, PEG-100 Stearate, Cyclopentasiloxane, Tocopherol (Vitamin E), Zea Mays Oil, Retinyl Palmitate (Vitamin A), Cholecalciferol (Vitamin D3), Oat Bran Extract, Glycerin, Allantoin, Caprylic/Capric Triglyceride, Glyceryl Dilaurate, Phenoxyethanol, DMDM Hydantoin, Iodopropynyl Butylcarbamate, PEG-8, Aluminum Starch Octenylsuccinate, Isohexadecane, Isopropyl Isostearate, Triethanolamine, Carbomer, Fragrance

Section 51945-4

BOA

VIDA

Recovery

Creme

to relieve and

replenish dry,

malnourished skin

Formulated

with Cupuacu Butter

5 oz. (148 mL)

Section 55105-1

Purpose

Skin protectant

Section 55106-9

Active Ingredients

Dimethicone 1.5% (w/w)


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily protects and helps relieve chapped or cracked skin

Beneficial for face, hands, body and legs

Dosage and Administration (34068-7)

Directions

Apply cream liberally as needed

Warnings and Precautions (34071-1)

Warnings

For External Use Only



Section 44425-7 (44425-7)

Other Information

Protect from freezing.

Avoid excessive heat

Section 50565-1 (50565-1)

Keep out of reach of children

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

condition worsens

symptoms last for more than 7 days or clear up and occur within a few days

Section 50567-7 (50567-7)

When using this product

do not get into eyes

Section 50570-1 (50570-1)

Do not use

on deep or puncture wounds

on animal bites

on serious burns

Section 51727-6 (51727-6)

Inactive Ingredients

Purified Water, Theobroma Grandiflorum Seed (Cupuacu Butter), Isopropyl Palmitate, Cetearyl Alcohol, Stearic Acid, Ceteareth 20, PEG-100 Stearate, Cyclopentasiloxane, Tocopherol (Vitamin E), Zea Mays Oil, Retinyl Palmitate (Vitamin A), Cholecalciferol (Vitamin D3), Oat Bran Extract, Glycerin, Allantoin, Caprylic/Capric Triglyceride, Glyceryl Dilaurate, Phenoxyethanol, DMDM Hydantoin, Iodopropynyl Butylcarbamate, PEG-8, Aluminum Starch Octenylsuccinate, Isohexadecane, Isopropyl Isostearate, Triethanolamine, Carbomer, Fragrance

Section 51945-4 (51945-4)

BOA

VIDA

Recovery

Creme

to relieve and

replenish dry,

malnourished skin

Formulated

with Cupuacu Butter

5 oz. (148 mL)

Section 55105-1 (55105-1)

Purpose

Skin protectant

Section 55106-9 (55106-9)

Active Ingredients

Dimethicone 1.5% (w/w)


Advanced Ingredient Data


Raw Label Data

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