Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 3829a721-7340-1f79-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-07-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 g)
Inactive Ingredients
Polyoxyl 40 Hydrogenated Castor Oil Carbomer Interpolymer Type A (55000 Cps) Water D&c Red No. 33 Trolamine Fd&c Blue No. 1 Fd&c Red No. 4

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-07-18
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

Warnings

■ For external use only ■ Flammable, keep away from fire & flame ■ Does not contain grain alcohol;do not drink. If taken internally will produce serious gastric disturbances

Directions

■ Rub dime sized amount between hands until dry ■ Supervise children in the use of this product ■ In the case of eye contact, rinse eyes thoroughly with water

Package Label

Active Ingredient

Alcohol 62%

Other Information

■ Store below 105°F ■ May discolor some fabrics

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Blue 1, Fragrance, PEG-40 Hydrogenated Castor Oil, Red 4, Red 33, Triethanolamine, Water

When Using This Product

■ Avoid the eyes and mucous membranes ■ In the case of eyes or mucous membrane contact, rinse area thoroughly with water

Stop Use and Ask A Doctor If

■ Condition worsens ■ Redness or irritation develops ■ If condition persists for more than 3 days

Keep Out of Reach of Children

If swallowed contact a doctor or Poison Control Center immediately.

Structured Label Content

Use

■ For handwashing to decrease bacteria on the skin

■ Recommended for repeated use

Purpose

Antiseptic

Warnings

■ For external use only ■ Flammable, keep away from fire & flame ■ Does not contain grain alcohol;do not drink. If taken internally will produce serious gastric disturbances

Directions

■ Rub dime sized amount between hands until dry ■ Supervise children in the use of this product ■ In the case of eye contact, rinse eyes thoroughly with water

Package Label

Active Ingredient

Alcohol 62%

Other Information (Other information)

■ Store below 105°F ■ May discolor some fabrics

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Blue 1, Fragrance, PEG-40 Hydrogenated Castor Oil, Red 4, Red 33, Triethanolamine, Water

When Using This Product (When using this product)

■ Avoid the eyes and mucous membranes ■ In the case of eyes or mucous membrane contact, rinse area thoroughly with water

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

■ Condition worsens ■ Redness or irritation develops ■ If condition persists for more than 3 days

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

If swallowed contact a doctor or Poison Control Center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:08.645539 · Updated: 2026-03-14T22:54:23.335310