SPL v1
SPL
SPL Set ID cb39a459-148e-4bfe-8846-cbd3eed4202b
Route
TOPICAL
Published
Effective Date 2021-10-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Glycerin Aloe Vera Leaf Calendula Officinalis Flower Morus Alba Root Fd&c Blue No. 1 Polysorbate 20 Trolamine Carbomer Homopolymer, Unspecified Type Camellia Sinensis Root Licorice Rosemary Artemisia Princeps Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-10-20

Description

Ethyl Alcohol 70% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70% v/v

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

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.

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.

Drug Facts

Product Label

Active Ingredient

Ethyl Alcohol 70% v/v

Other Information
  • Store between 15-30C (59-86F)

• Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Aqua, Glycerin, Aloe vera leaf , Carbomer, Triethanolamine, Mugwort extract, Calendula officinalis flower, Camellia Sinensis Leaf Extract, Mulberry root extract, Licorice extract, Rosmarinus officinalis (Rosmary) leaf oil, Polysorbate 20, Fragrance, FD&C BLUE NO. 1


Structured Label Content

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

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.

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.

Drug Facts

Product Label (Product label)

Active Ingredient (Active ingredient)

Ethyl Alcohol 70% v/v

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 , Carbomer, Triethanolamine, Mugwort extract, Calendula officinalis flower, Camellia Sinensis Leaf Extract, Mulberry root extract, Licorice extract, Rosmarinus officinalis (Rosmary) leaf oil, Polysorbate 20, Fragrance, FD&C BLUE NO. 1


Advanced Ingredient Data


Raw Label Data

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