75701-008

75701-008
SPL v12
SPL
SPL Set ID b0715bcf-a20c-bbbe-e053-2995a90a7a2c
Route
TOPICAL
Published
Effective Date 2020-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
D&c Red No. 33 Fragrance Clean Orc0600327 Deanol Lavandula Angustifolia Flower Glycerin Trolamine Water Alpha-tocopherol Acetate Propylene Glycol Carbomer Homopolymer, Unspecified Type Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-24

Description

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Ethyl Alcohol 70% v/v

Use

Hand Sanitizer to help reduce bacteria on skin.

Section 50566-9

Stop use and ask doctor if irritation or rash appears and lasts.

Warnings

Flammable. Keep away from fire or flame.

For external use only.

When using this product, do not use in or near the eyes.

In case of contact, rinse eyes thoroughly with water.

Stop use and ask doctor if irritation or rash appears and lasts.

Keep out of reach for children. If swallowed, get medical help or contact a

Poison Control Center right away.

Directions

Place enough Product in your palm to thoroughly spread on both hands and rub into the skin until dry.

Children under 6 years of age should be supervised when using this product.

Do Not Use

do not use in or near the eyes.

Other Information

Store below 106°F. (41°C)

May discolor certain fabrics or surfaces

Active Ingredient(s)

Ethyl Alcohol 70% v/v

Inactive Ingredients

Water(Aqua), Lavandula Angustufolia(Lavender) Flower Extract, Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine,D&C Red No.33,FD&C Blue No I, 2-(Dimethylamino) Ethanol.

When Using This Product

When using this product, do not use in or near the eyes.

In case of contact, rinse eyes thoroughly with water.

Stop use and ask doctor if irritation or rash appears and lasts.

Keep out of reach for children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep Out of Reach of Children.

Keep out of reach for children. If swallowed, get medical help or contact a Poison Control Center right away.

Package Label Principal Display Panel


Structured Label Content

Use

Hand Sanitizer to help reduce bacteria on skin.

Section 50566-9 (50566-9)

Stop use and ask doctor if irritation or rash appears and lasts.

Purpose

Antimicrobial

Warnings

Flammable. Keep away from fire or flame.

For external use only.

When using this product, do not use in or near the eyes.

In case of contact, rinse eyes thoroughly with water.

Stop use and ask doctor if irritation or rash appears and lasts.

Keep out of reach for children. If swallowed, get medical help or contact a

Poison Control Center right away.

Directions

Place enough Product in your palm to thoroughly spread on both hands and rub into the skin until dry.

Children under 6 years of age should be supervised when using this product.

Do Not Use (Do not use)

do not use in or near the eyes.

Other Information (Other information)

Store below 106°F. (41°C)

May discolor certain fabrics or surfaces

Active Ingredient(s)

Ethyl Alcohol 70% v/v

Inactive Ingredients (Inactive ingredients)

Water(Aqua), Lavandula Angustufolia(Lavender) Flower Extract, Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine,D&C Red No.33,FD&C Blue No I, 2-(Dimethylamino) Ethanol.

When Using This Product (When using this product)

When using this product, do not use in or near the eyes.

In case of contact, rinse eyes thoroughly with water.

Stop use and ask doctor if irritation or rash appears and lasts.

Keep out of reach for children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep Out of Reach of Children. (Keep out of reach of children.)

Keep out of reach for children. If swallowed, get medical help or contact a Poison Control Center right away.

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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