SPL v1
SPL
SPL Set ID 169c55bf-6eeb-4279-9b02-3f83a8cefc9e
Route
TOPICAL
Published
Effective Date 2020-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Glycerin Water Carbomer 934 Propylene Glycol Alpha-tocopherol Acetate Triethanolamine Sulfate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-23

Description

NA

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

NA

Use

Hand sanitizer to help reduce bacteria on the skin

Section 42229-5

NA

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 irritation or rash appears and lasts

Section 50567-7

When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

Section 51945-4

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 untill dry

Children under 6 years of age shoud be supervised when using this 

Other Information

Do not store above 106F (41C)

May discolor certain fabrics or surfaces

Active Ingredient(s)

Ethyl Alcohol 70% v/v

Inactive Ingredients

Water, aloe barbadensis leaf extract, carbomer, fragrance, propylene glycol, glycerin, tocopheryl acetate, Triethanolamine


Structured Label Content

Use

Hand sanitizer to help reduce bacteria on the skin

Section 42229-5 (42229-5)

NA

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 irritation or rash appears and lasts

Section 50567-7 (50567-7)

When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

Section 51945-4 (51945-4)

Purpose

Antimicrobial

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 untill dry

Children under 6 years of age shoud be supervised when using this 

Other Information (Other information)

Do not store above 106F (41C)

May discolor certain fabrics or surfaces

Active Ingredient(s)

Ethyl Alcohol 70% v/v

Inactive Ingredients (Inactive ingredients)

Water, aloe barbadensis leaf extract, carbomer, fragrance, propylene glycol, glycerin, tocopheryl acetate, Triethanolamine


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)