SPL v1
SPL
SPL Set ID 7c4747b8-1918-4954-a9db-72ee2bd9c427
Route
TOPICAL
Published
Effective Date 2018-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (0.3 g)
Inactive Ingredients
Water Cetyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-07-01

Description

Active ingredients: Dimethicone 1.0%

Purpose

Purpose: Skin Protectant


Medication Information

Purpose

Purpose: Skin Protectant

Description

Active ingredients: Dimethicone 1.0%

Uses

Uses:

Containing the energy of Jeju camphor tree and vegetable butter ingredient, it delivers abundant nutrients. It presents delicate fragrance of jasmine and its soft embracement.

Warnings

Warnings:

For external use only.

Avoid contact with eyes.

Discontinue use if signs of irritation or rashes appear.

Replace the cap after use.

Keep out of reach of children

Directions

Directions:

After washing hands, apply adequte amount onto skin with soft massage.

Active Ingredient

Active ingredients: Dimethicone 1.0%

Inactive Ingredient

Inactive ingredients:

Water,Cetyl Alcohol,Glycerin,Butylene Glycol,Cetyl Ethylhexanoate,Stearic Acid,Beeswax,Butyrospermum Parkii (Shea) Butter,Helianthus Annuus (Sunflower) Seed Oil,Cinnamomum Camphora (Camphor) Leaf Extract,Chrysanthemum Zawadskii Extract,Sasa Quelpaertensis Extract,Vitex Trifolia Fruit Extract,Benzyl Alcohol,Pyrus Malus (Apple) Fruit Extract,Prunus Serotina (Wild Cherry) Fruit Extract,Ethoxydiglycol,Mangifera Indica (Mango) Seed Butter,Glyceryl Stearate,PEG-100 Stearate,Caprylhydroxamic Acid,Caprylyl Glycol,Arginine,Carbomer,Polysorbate 60,Sorbitan Sesquioleate,Fragrance,Disodium EDTA

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Uses

Uses:

Containing the energy of Jeju camphor tree and vegetable butter ingredient, it delivers abundant nutrients. It presents delicate fragrance of jasmine and its soft embracement.

Purpose (PURPOSE)

Purpose: Skin Protectant

Warnings (WARNINGS)

Warnings:

For external use only.

Avoid contact with eyes.

Discontinue use if signs of irritation or rashes appear.

Replace the cap after use.

Keep out of reach of children

Directions

Directions:

After washing hands, apply adequte amount onto skin with soft massage.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Dimethicone 1.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients:

Water,Cetyl Alcohol,Glycerin,Butylene Glycol,Cetyl Ethylhexanoate,Stearic Acid,Beeswax,Butyrospermum Parkii (Shea) Butter,Helianthus Annuus (Sunflower) Seed Oil,Cinnamomum Camphora (Camphor) Leaf Extract,Chrysanthemum Zawadskii Extract,Sasa Quelpaertensis Extract,Vitex Trifolia Fruit Extract,Benzyl Alcohol,Pyrus Malus (Apple) Fruit Extract,Prunus Serotina (Wild Cherry) Fruit Extract,Ethoxydiglycol,Mangifera Indica (Mango) Seed Butter,Glyceryl Stearate,PEG-100 Stearate,Caprylhydroxamic Acid,Caprylyl Glycol,Arginine,Carbomer,Polysorbate 60,Sorbitan Sesquioleate,Fragrance,Disodium EDTA

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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