2f3b738d-981f-46f4-9b9d-fe1a247fa323

SPL v1
SPL
SPL Set ID 2f3b738d-981f-46f4-9b9d-fe1a247fa323
Route
topical
Published
Effective Date 2021-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (68 mL)
Inactive Ingredients
water glycerin aloe vera leaf artemisia princeps leaf calendula officinalis flower morus alba root licorice rosemary oil polysorbate 20 green tea leaf fd&c blue no. 1 fd&c yellow no. 5

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2021-09-20

Purpose

Antiseptic

Description

Ethyl Alcohol 68% v/v


Medication Information

Warnings

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.

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

Uses

Hand sanitizer to help reduce bacteria that potentially can cause

disease. For use when soap and water are not available.

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

Purpose

Antiseptic

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.

• Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Store between 15-30C (59-86F) • Avoid freezing and excessive

heat above 40C (104F)

Inactive Ingredients

Aqua, Glycerin, Aloe Vera Leaf, Mugwort Extract, Calendula Officinalis Flower,

Camellia Sinensis Leaf Extract, Mulberry Root Extract, Licorice Extract, Rosmarinus Officinalis (Rosemary) Leaf Oil, Polysorbate 20, Fragrance, FD&C Blue No. 1, FD&C Yellow No. 5

Description

Ethyl Alcohol 68% v/v

Drug Facts

Product Label

Active Ingredient

Ethyl Alcohol 68% v/v


Structured Label Content

Warnings

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.

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

Uses

Hand sanitizer to help reduce bacteria that potentially can cause

disease. For use when soap and water are not available.

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

Purpose

Antiseptic

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.

• Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information (Other information)

Store between 15-30C (59-86F) • Avoid freezing and excessive

heat above 40C (104F)

Inactive Ingredients (Inactive ingredients)

Aqua, Glycerin, Aloe Vera Leaf, Mugwort Extract, Calendula Officinalis Flower,

Camellia Sinensis Leaf Extract, Mulberry Root Extract, Licorice Extract, Rosmarinus Officinalis (Rosemary) Leaf Oil, Polysorbate 20, Fragrance, FD&C Blue No. 1, FD&C Yellow No. 5

Drug Facts

Product Label (Product label)

Active Ingredient (Active ingredient)

Ethyl Alcohol 68% v/v


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)