85279-001

85279-001
SPL v3
SPL
SPL Set ID 2e8b5afe-6ff8-3e9b-e063-6394a90ad703
Route
CUTANEOUS
Published
Effective Date 2025-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (60 g)
Inactive Ingredients
Carbomer Water Taraxacum Officinale (dandelion) Root Aminomethyl Propanol Tussilago Farfara Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-20

Description

Ethyl Alcohol 60%

Purpose

Antimicrobia


Medication Information

Purpose

Antimicrobia

Description

Ethyl Alcohol 60%

Use

Handsanitizer to help reduce bacteria on the skin.

Section 50565-1

Keepout of reach of children. If swallowed, get medical help orcontacta

Poison Control Center right away.

Section 50566-9

Stop useand askadoctorifir ritation or rash appears and lasts.

Section 50567-7

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

Warnings

For external use only.

Directions

●Place enough product in your palm to thoroughly spread

onboth hands and rub into the skin until dry.

●Children under 6 years of age should be supervised when

using this porduct.

Do Not Use

Do not use near the eyesIn case of contact, rinse eyes thoroughly with water.

Other Information

●Store below 106'F (41°C)

●May discolor certain fabrics or surfaces

●Validity period after opening: 12 months

Active Ingredient(s)

Ethyl Alcohol 60%

Inactive Ingredients

Water, Carbomer, Dandelion Extract, Winter FlowerExtract, Aminomethyl Propanol

Package Label Principal Display Panel


Structured Label Content

Use

Handsanitizer to help reduce bacteria on the skin.

Section 50565-1 (50565-1)

Keepout of reach of children. If swallowed, get medical help orcontacta

Poison Control Center right away.

Section 50566-9 (50566-9)

Stop useand askadoctorifir ritation or rash appears and lasts.

Section 50567-7 (50567-7)

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

Purpose

Antimicrobia

Warnings

For external use only.

Directions

●Place enough product in your palm to thoroughly spread

onboth hands and rub into the skin until dry.

●Children under 6 years of age should be supervised when

using this porduct.

Do Not Use (Do not use)

Do not use near the eyesIn case of contact, rinse eyes thoroughly with water.

Other Information (Other information)

●Store below 106'F (41°C)

●May discolor certain fabrics or surfaces

●Validity period after opening: 12 months

Active Ingredient(s)

Ethyl Alcohol 60%

Inactive Ingredients (Inactive ingredients)

Water, Carbomer, Dandelion Extract, Winter FlowerExtract, Aminomethyl Propanol

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)