SPL v1
SPL
SPL Set ID a99512ed-aff2-472b-bc25-10a552e92d09
Route
TOPICAL
Published
Effective Date 2014-05-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 g)
Inactive Ingredients
Water Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Glycerin Propylene Glycol Trolamine Fd&c Yellow No. 5 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-05-16

Description

Alcohol 62%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol 62%

Use

■ For handwashing to decrease bacteria on the skin

■ Recommended for repeated use

Section 51945-4
Warnings

Flammable, keep away from fire and flame.

For external use only. Do not use in the eyes or apply over large areas of the body.

In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

Use only as directed. Do not drink. If taken internally, it will produce serious gastric disturbances.

Directions

Active Ingredient

Alcohol 62%

Other Information

■ Store below 105F(40.5C) ■ May discolor some fabrics

Inactive Ingredients

Water, Carbomer, Glycerin, Propylene Glycol, Fragrance, Triethanolamine, FD&C Blue NO.1, FD&C Yellow NO.5

Stop Use and Ask A Doctor If

■ Irritation persists for more than 72 hours.

■ Supervise children in the use of this product.

Keep Out of Reach of Children

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


Structured Label Content

Use

■ For handwashing to decrease bacteria on the skin

■ Recommended for repeated use

Section 51945-4 (51945-4)
Purpose

Antiseptic

Warnings

Flammable, keep away from fire and flame.

For external use only. Do not use in the eyes or apply over large areas of the body.

In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

Use only as directed. Do not drink. If taken internally, it will produce serious gastric disturbances.

Directions

Active Ingredient (Active ingredient)

Alcohol 62%

Other Information (Other information)

■ Store below 105F(40.5C) ■ May discolor some fabrics

Inactive Ingredients (Inactive ingredients)

Water, Carbomer, Glycerin, Propylene Glycol, Fragrance, Triethanolamine, FD&C Blue NO.1, FD&C Yellow NO.5

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ Irritation persists for more than 72 hours.

■ Supervise children in the use of this product.

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

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)