SPL v4
SPL
SPL Set ID ba9611a3-e2a4-4835-9ffe-aafe85a7cb9c
Route
TOPICAL
Published
Effective Date 2024-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-09-14
Description

Ethanol 70% v/v

Medication Information

Warnings and Precautions

For external use only. Flammable. Keep away from children.

Indications and Usage

Apply lotion directly onto body and rub with hands until dry. Product may be used on all skin surfaces. Children under 6 years of age should be supervised when using this product.

Dosage and Administration

Apply lotion directly onto body and rub with hands until dry. Product may be used on all skin surfaces. Children under 6 years of age should be supervised when using this product.

Description

Ethanol 70% v/v

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

If redness or irritation develop and persist for more than 72 hours.

Section 50567-7

Do not use in or near eyes. In case of eye contact, rinse thoroughly with water.

Section 51727-6

Water (aqua), glycereth-18 (and) glycereth-18 ethylhexanoate, cetyl alcohol, glyceryl monostearate, ethylene glycol distearate, Vitamin A (retinyl palmitate), Vitamin C (magnesium ascorbyl phosphate), Vitamin E d-l alpha tocopherol acetate), acrylate crosspolymer, fragrance (parfum), 2-amino-2-methyl-1-propanol, FD&C Red #40, FD&C Blue #1.

Section 51945-4

Section 53413-1

Call 1-888-300-1225, Monday through Friday 8:00AM to 5:00PM EST/EDT.

Section 55105-1

Antimicrobial

Section 55106-9

Ethanol 70% v/v

Section 60561-8

Do not store above 110oF (43oC). For additional information, see Safety Data Sheet (SDS).

Structured Label Content

Indications and Usage (34067-9)

Apply lotion directly onto body and rub with hands until dry. Product may be used on all skin surfaces. Children under 6 years of age should be supervised when using this product.

Dosage and Administration (34068-7)

Apply lotion directly onto body and rub with hands until dry. Product may be used on all skin surfaces. Children under 6 years of age should be supervised when using this product.

Warnings and Precautions (34071-1)

For external use only. Flammable. Keep away from children.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

If redness or irritation develop and persist for more than 72 hours.

Section 50567-7 (50567-7)

Do not use in or near eyes. In case of eye contact, rinse thoroughly with water.

Section 51727-6 (51727-6)

Water (aqua), glycereth-18 (and) glycereth-18 ethylhexanoate, cetyl alcohol, glyceryl monostearate, ethylene glycol distearate, Vitamin A (retinyl palmitate), Vitamin C (magnesium ascorbyl phosphate), Vitamin E d-l alpha tocopherol acetate), acrylate crosspolymer, fragrance (parfum), 2-amino-2-methyl-1-propanol, FD&C Red #40, FD&C Blue #1.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Call 1-888-300-1225, Monday through Friday 8:00AM to 5:00PM EST/EDT.

Section 55105-1 (55105-1)

Antimicrobial

Section 55106-9 (55106-9)

Ethanol 70% v/v

Section 60561-8 (60561-8)

Do not store above 110oF (43oC). For additional information, see Safety Data Sheet (SDS).

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:44.367824 · Updated: 2026-03-14T23:03:57.888673