SPL v1
SPL
SPL Set ID a2bffb7f-c5a4-ae54-e053-2995a90ab973
Route
TOPICAL
Published
Effective Date 2020-04-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Glycereth-26 Carbomer Homopolymer, Unspecified Type Sodium Hydroxide Water Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-08

Description

Ethyl Alcohol 75%

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Ethyl Alcohol 75%

Uses

Hand sanitizer to help reduce bacteria on skin.

Warnings

Flammable, Keep away from fire or flame.

For external use only.

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.

Active Ingredient

Ethyl Alcohol 75%

Other Information

Store below 106° F.(41℃)

Inactive Ingredients

Alcohol, Aqua, Glycereth-26, Aloe Barbadensis Leaf Extract,Carbomer,Sodium Hydroxide.

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.

Package Label Principal Display Panel


Structured Label Content

Uses

Hand sanitizer to help reduce bacteria on skin.

Purpose

Antimicrobial

Warnings (WARNINGS)

Flammable, Keep away from fire or flame.

For external use only.

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.

Active Ingredient

Ethyl Alcohol 75%

Other Information

Store below 106° F.(41℃)

Inactive Ingredients (INACTIVE INGREDIENTS)

Alcohol, Aqua, Glycereth-26, Aloe Barbadensis Leaf Extract,Carbomer,Sodium Hydroxide.

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.

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


Advanced Ingredient Data


Raw Label Data

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