Drug Facts 62654-144

Drug Facts 62654-144
SPL v5
SPL
SPL Set ID 44c98a3f-02f1-46ae-9fb0-1eb822b5ceaf
Route
TOPICAL
Published
Effective Date 2011-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (2 g)
Inactive Ingredients
Water Polyglyceryl-4 Isostearate Hexyl Laurate Quadrosilan Cyclomethicone 5 Mineral Oil Isopropyl Palmitate Ethylhexyl Palmitate Theobroma Grandiflorum Seed Glycerin Tocopherol Yellow Wax Diazolidinyl Urea Hydrogenated Castor Oil Vitamin A Palmitate Cholecalciferol Corn Oil Methylparaben Sodium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-11-01

Description

Active Ingredients Dimethicone 2.0% (w/w)


Medication Information

Warnings and Precautions

Warnings

For External Use Only

Indications and Usage

Uses

Helps treat and prevent diaper rash

Protects minor skin irritation due to diaper rash and helps seal out wetness

Temporarily protects and helps relieve chapped or cracked skin

Dosage and Administration

Directions

Apply liberally as often as needed

Description

Active Ingredients Dimethicone 2.0% (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 again 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

Water, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate,Cyclotetrasiloxane, Cyclopentasiloxane, Mineral Oil, Isopropyl Palmitate, Ethylhexyl Palmitate, Theobroma Grandiflorum Seed (Cupuacu Butter), Glycerin, Cetyl Dimethicone, Tocopherol (Vitamin E), Beeswax, Diazolidinyl Urea, Hydrogenated Castor Oil, Retinyl Palmitate (Vitamin A), Cholecalciferol (Vitamin D3), Beeswax, Zea Mays Oil, Methyl Paraben, Fragrance, Sodium Chloride





Section 51945-4

BOA

VIDA

Canopy

skin protectant

helps prevent minor

skin irritation

Formulated

with

Cupuacu Butter

5 fl oz. (148 mL)

Section 55105-1

Purpose

Skin protectant

Section 55106-9

Active Ingredients

Dimethicone 2.0% (w/w)


Structured Label Content

Indications and Usage (34067-9)

Uses

Helps treat and prevent diaper rash

Protects minor skin irritation due to diaper rash and helps seal out wetness

Temporarily protects and helps relieve chapped or cracked skin

Dosage and Administration (34068-7)

Directions

Apply liberally as often 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 again 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

Water, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate,Cyclotetrasiloxane, Cyclopentasiloxane, Mineral Oil, Isopropyl Palmitate, Ethylhexyl Palmitate, Theobroma Grandiflorum Seed (Cupuacu Butter), Glycerin, Cetyl Dimethicone, Tocopherol (Vitamin E), Beeswax, Diazolidinyl Urea, Hydrogenated Castor Oil, Retinyl Palmitate (Vitamin A), Cholecalciferol (Vitamin D3), Beeswax, Zea Mays Oil, Methyl Paraben, Fragrance, Sodium Chloride





Section 51945-4 (51945-4)

BOA

VIDA

Canopy

skin protectant

helps prevent minor

skin irritation

Formulated

with

Cupuacu Butter

5 fl oz. (148 mL)

Section 55105-1 (55105-1)

Purpose

Skin protectant

Section 55106-9 (55106-9)

Active Ingredients

Dimethicone 2.0% (w/w)


Advanced Ingredient Data


Raw Label Data

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