8b1bf2e6-bcc6-4cc5-9fcb-72cb0d333451

SPL v1
SPL
SPL Set ID 8b1bf2e6-bcc6-4cc5-9fcb-72cb0d333451
Route
topical
Published
Effective Date 2020-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (310 mL)
Inactive Ingredients
aloe butylene glycol carbomer homopolymer, unspecified type panthenol trolamine water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-09-01

Purpose

Antiseptic

Description

Alcohol 62% v/v


Medication Information

Warnings

For external use only. Flammable. Keep away from heat or flame

--------------------------------------------------------------------------------------------------------

Do not use

• in children less than 2 months of age

• on open skin wounds

--------------------------------------------------------------------------------------------------------

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

--------------------------------------------------------------------------------------------------------

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Uses

• Hand sanitizer to help reduce bacteria that potentially can cause disease.

• For use when soap and water are not available.

Purpose

Antiseptic

Directions

• Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

• Supervise children in the use of this product.

Other Information

• Store between 59-86℉ (15-30℃)

• Avoid freezing and excessive heat above 104℉ (40℃)

Inactive Ingredients

Aloe Extract, Butylene Glycol, CARBOMER, DL-Panthenol, Polyoxyethylene Hydrogenetated Caster Oil, Triethanolamine, Water

Description

Alcohol 62% v/v

Active Ingredient

Alcohol 62% v/v

Keep Out of Reach of Children

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

Package Label.principal Display Panel


Structured Label Content

Warnings (WARNINGS)

For external use only. Flammable. Keep away from heat or flame

--------------------------------------------------------------------------------------------------------

Do not use

• in children less than 2 months of age

• on open skin wounds

--------------------------------------------------------------------------------------------------------

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

--------------------------------------------------------------------------------------------------------

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Uses

• Hand sanitizer to help reduce bacteria that potentially can cause disease.

• For use when soap and water are not available.

Purpose (PURPOSE)

Antiseptic

Directions

• Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

• Supervise children in the use of this product.

Other Information (Other information)

• Store between 59-86℉ (15-30℃)

• Avoid freezing and excessive heat above 104℉ (40℃)

Inactive Ingredients (INACTIVE INGREDIENTS)

Aloe Extract, Butylene Glycol, CARBOMER, DL-Panthenol, Polyoxyethylene Hydrogenetated Caster Oil, Triethanolamine, Water

Active Ingredient (ACTIVE INGREDIENT)

Alcohol 62% v/v

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

Keep out of reach of 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

All Sections (JSON)