SPL v2
SPL
SPL Set ID 03010837-0289-3e08-e063-6394a90a7d04
Route
TOPICAL
Published
Effective Date 2023-08-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (83 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-16

Description

alcohol


Medication Information

Warnings and Precautions

Flammable, keep away from fire and flames

For external use only

Indications and Usage

■ Apply to the area to be disinfected

■ Supervise children under 6 years of age when using this product to avoid swallowing

Dosage and Administration

For external use only

Description

alcohol

Section 50565-1

Keep out of reach of children

Section 51727-6

water

Section 51945-4

Section 55105-1

Disinfection of hands and skin, disinfection of surgical site skin

Section 55106-9

alcohol


Structured Label Content

Indications and Usage (34067-9)

■ Apply to the area to be disinfected

■ Supervise children under 6 years of age when using this product to avoid swallowing

Dosage and Administration (34068-7)

For external use only

Warnings and Precautions (34071-1)

Flammable, keep away from fire and flames

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Disinfection of hands and skin, disinfection of surgical site skin

Section 55106-9 (55106-9)

alcohol


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)