c8b31580-5672-61de-e053-2995a90a3e78

SPL v11
SPL
SPL Set ID c8b31580-5672-61de-e053-2995a90a3e78
Route
topical
Published
Effective Date 2023-04-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (0.001 kg)
Inactive Ingredients
vanillin benzyl benzoate isopropyl myristate lactic acid water hydroxypropyl cellulose, unspecified panthenol propylene glycol sodium salicylate glycerin sodium lauryl sulfate niacinamide adipic acid benzoic acid salicylic acid glycine copper gluconate acetic acid sodium chloride orange oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-08-16

Purpose

Antiseptic

Description

Ethyl Alcohol 63% by volume


Medication Information

Uses

Antiseptic rub and hand sanitizer to help reduce bacteria and viruses on skin that could cause disease. For use when soap and water are not available.

Purpose

Antiseptic

Directions

Wet hands thoroughly with product and rub hands together, palms, backs and nails, until dry, without wiping. Children under 6 years of age should be supervised when using this product.

Description

Ethyl Alcohol 63% by volume

Section 50565-1

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

Warnings:

Flammable. Keep away from fire and flame.

For external use only. Do not ingest.

When using this product, do not use in or near eyes.

In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor, if irritation or rash appears and lasts.

Directions:

Wet hands thoroughly with product and rub hands together, palms, backs and nails and wrists, until dry, without wiping. Children under 6 years of age should be supervised when using this product.

Package Label

Active Ingredient

Ethyl Alcohol 63% by volume

Other Information:

Store below 110° F (43 C).

•Dried product may turn brown from copper oxide.

•May discolor certain fabrics or surfaces.

Inactive Ingredients:

Water, glycerin, propylene glycol, sodium salicylate, panthenol,‡ sodium lauryl sulfate, salicylic acid, hydroxypropyl cellulose, lactic acid, niacinamide,** isopropyl myristate, fragrance, copper gluconate, benzoic acid, orange oil, adipic acid, acetic acid, glycine, sodium chloride. **Vitamin B3, ‡Pro-vitamin B5


Structured Label Content

Uses

Antiseptic rub and hand sanitizer to help reduce bacteria and viruses on skin that could cause disease. For use when soap and water are not available.

Purpose

Antiseptic

Directions

Wet hands thoroughly with product and rub hands together, palms, backs and nails, until dry, without wiping. Children under 6 years of age should be supervised when using this product.

Section 50565-1 (50565-1)

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

Warnings:

Flammable. Keep away from fire and flame.

For external use only. Do not ingest.

When using this product, do not use in or near eyes.

In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor, if irritation or rash appears and lasts.

Directions:

Wet hands thoroughly with product and rub hands together, palms, backs and nails and wrists, until dry, without wiping. Children under 6 years of age should be supervised when using this product.

Package Label

Active Ingredient

Ethyl Alcohol 63% by volume

Other Information:

Store below 110° F (43 C).

•Dried product may turn brown from copper oxide.

•May discolor certain fabrics or surfaces.

Inactive Ingredients:

Water, glycerin, propylene glycol, sodium salicylate, panthenol,‡ sodium lauryl sulfate, salicylic acid, hydroxypropyl cellulose, lactic acid, niacinamide,** isopropyl myristate, fragrance, copper gluconate, benzoic acid, orange oil, adipic acid, acetic acid, glycine, sodium chloride. **Vitamin B3, ‡Pro-vitamin B5


Advanced Ingredient Data


Raw Label Data

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