SPL v1
SPL
SPL Set ID ad12f690-e546-7216-e053-2a95a90aaa53
Route
TOPICAL
Published
Effective Date 2020-08-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Glycerin Water Methyl Gluceth-10 Carbomer Interpolymer Type A (55000 Cps) Chloroxylenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-01
Description

Alcohol 75%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Alcohol 75%

Use

For decreasing bacteria on the skin

Warnings
  • For external use only
  • Flammable, keep away from fire and flame
  • Dose not contain grain alcohol; do not drink. If taken internally will produce serious gastric disturbances.
Directions
  • Place enough Product in your palm to cover hands and rub hands together briskyly until dry.
  • Supervise children in the use of this product.
  • In the case of eye contact, rinse eyes thoroughly with water.
Active Ingredient

Alcohol 75%

Other Information
  • Store between 15-30°C (59-86F).
  • Avoid freezing and excessive heat above 40°C (104F).
Inactive Ingredients

Ammonium acryloyldimethyltaurate/vp copolymer, chloroxylenol, glycerin, methyl gluceth-10, water.

When Using This Product

When using this product

  • Aviod the eyes and mucous membrances
  • In the case of eyes and mucous membrances 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.

Package Label/principal Display Panel

NDC 78692-613-34; 100 mL

Structured Label Content

Use

For decreasing bacteria on the skin

Purpose

Antiseptic

Warnings
  • For external use only
  • Flammable, keep away from fire and flame
  • Dose not contain grain alcohol; do not drink. If taken internally will produce serious gastric disturbances.
Directions
  • Place enough Product in your palm to cover hands and rub hands together briskyly until dry.
  • Supervise children in the use of this product.
  • In the case of eye contact, rinse eyes thoroughly with water.
Active Ingredient

Alcohol 75%

Other Information (Other information)
  • Store between 15-30°C (59-86F).
  • Avoid freezing and excessive heat above 40°C (104F).
Inactive Ingredients (Inactive ingredients)

Ammonium acryloyldimethyltaurate/vp copolymer, chloroxylenol, glycerin, methyl gluceth-10, water.

When Using This Product (When using this product)

When using this product

  • Aviod the eyes and mucous membrances
  • In the case of eyes and mucous membrances contact, rinse area thoroughly with water
Stop Use and Ask A Doctor If (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)

Keep out of reach of children

If swallowed contact a doctor or Poison Control Center immediately.

Package Label/principal Display Panel (Package Label/Principal Display Panel)

NDC 78692-613-34; 100 mL

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:36.998211 · Updated: 2026-03-14T22:58:14.813588