70483-018

70483-018
SPL v1
SPL
SPL Set ID b1c5fc25-2cf1-6699-e053-2a95a90a9dea
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Glycerin Propylene Glycol Water Trolamine Fragrance Clean Orc0600327 Fd&c Red No. 40 Fd&c Blue No. 1 Fd&c Yellow No. 5 Carbomer Homopolymer, Unspecified Type Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Description

Ethyl Alcohol 70%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70%

Use

Hand sanitizer to help decrease bacteria on the skin when water, soap & towel are not available. Recommended for repeated use

Section 50565-1

Keep out of reach of children. Children must be supervised in use of this product.

Section 50566-9

Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours.

Section 50567-7

When using this product, avoid contact with eyes. In case of contact, flush eyes with water.

Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours.

Keep out of reach of children. Children must be supervised in use of this product.

Directions

Squeeze as needed into your palms and thoroughly spread on bottom hands. Rub into skin until dry.

Do Not Use

Do not apply around eyes. Do not use in ears or mouth.

Other Information

Do not store in temperature over 118°F.

Active Ingredient(s)

Ethyl Alcohol 70%

Inactive Ingredients

Water, Propylene Glycol, Glycerin, Carbomer, Aloe Barbadensis Leaf Juice, Triethanolamine, Fragrance. May Contain: FD & C Red No. 4, FD & C Blue No. 1, FD & C Yellow No 5.

Package Label Principal Display Panel


Structured Label Content

Use

Hand sanitizer to help decrease bacteria on the skin when water, soap & towel are not available. Recommended for repeated use

Section 50565-1 (50565-1)

Keep out of reach of children. Children must be supervised in use of this product.

Section 50566-9 (50566-9)

Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours.

Section 50567-7 (50567-7)

When using this product, avoid contact with eyes. In case of contact, flush eyes with water.

Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours.

Keep out of reach of children. Children must be supervised in use of this product.

Purpose

Antiseptic

Directions

Squeeze as needed into your palms and thoroughly spread on bottom hands. Rub into skin until dry.

Do Not Use (Do not use)

Do not apply around eyes. Do not use in ears or mouth.

Other Information (Other information)

Do not store in temperature over 118°F.

Active Ingredient(s)

Ethyl Alcohol 70%

Inactive Ingredients (Inactive ingredients)

Water, Propylene Glycol, Glycerin, Carbomer, Aloe Barbadensis Leaf Juice, Triethanolamine, Fragrance. May Contain: FD & C Red No. 4, FD & C Blue No. 1, FD & C Yellow No 5.

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


Advanced Ingredient Data


Raw Label Data

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