008 Hand Sanitizer

008 Hand Sanitizer
SPL v1
SPL
SPL Set ID ab1d8069-2c4e-056c-e053-2a95a90acf2e
Route
TOPICAL
Published
Effective Date 2020-06-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
D&c Red No. 33 Fd&c Blue No. 1 Fd&c Red No. 4 Polyoxyl 40 Hydrogenated Castor Oil Water Trolamine Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-23
Description

Ethyl alcohol 62%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl alcohol 62%

Uses

Helps reduce bacteria that potentially can cause disease

Helps prevent cross contamination on contact

Recommended for repeated use

Section 50566-9

Stop use and consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops

Section 50570-1

Avoid contact with eyes , in the case of eyes contact, rinse eyes thoroughly with water.

Warnings

Flammable, keep away from open flame and sources of heat

External use only

Avoid contact with eyes , in the case of eyes contact, rinse eyes thoroughly with water.

Stop use and consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops

Keep out of reach of children

Directions

Wet hands thoroughly with product and rub completely covering hands

·Allow to dry without wiping

·Children under the age of 6 should use with adult supervision

Not recommended for infants

Active Ingredient

Ethyl alcohol 62%

Other Information

Store below 105F(41C)

May discolor certain fabrics or surfaces.

Inactive Ingredients

Water, Acrylates/C10- Alkyl Acrylate Crosspolymer, Triethanolamine, Fragrance

PEG-40 Hydrogenated Castor Oil. May man FD&C RED NO 4( 14700), D& REN0.33(C 17200), FD&C YELLOW NO 5(C 19140), FD&C BLUE NO. 1(CI 42090)

Keep Out of Reach of Children

Keep out of reach of children

If swallowed, call a poison control center or get medical help right away .

Package Label Principal Display Panel

Structured Label Content

Uses

Helps reduce bacteria that potentially can cause disease

Helps prevent cross contamination on contact

Recommended for repeated use

Section 50566-9 (50566-9)

Stop use and consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops

Section 50570-1 (50570-1)

Avoid contact with eyes , in the case of eyes contact, rinse eyes thoroughly with water.

Purpose

Antiseptic

Warnings

Flammable, keep away from open flame and sources of heat

External use only

Avoid contact with eyes , in the case of eyes contact, rinse eyes thoroughly with water.

Stop use and consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops

Keep out of reach of children

Directions

Wet hands thoroughly with product and rub completely covering hands

·Allow to dry without wiping

·Children under the age of 6 should use with adult supervision

Not recommended for infants

Active Ingredient (Active ingredient)

Ethyl alcohol 62%

Other Information (Other information)

Store below 105F(41C)

May discolor certain fabrics or surfaces.

Inactive Ingredients (Inactive ingredients)

Water, Acrylates/C10- Alkyl Acrylate Crosspolymer, Triethanolamine, Fragrance

PEG-40 Hydrogenated Castor Oil. May man FD&C RED NO 4( 14700), D& REN0.33(C 17200), FD&C YELLOW NO 5(C 19140), FD&C BLUE NO. 1(CI 42090)

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children

If swallowed, call a poison control center or get medical help right away .

Package Label Principal Display Panel

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:17.510752 · Updated: 2026-03-14T22:57:45.410763