ad12f690-e546-7216-e053-2a95a90aaa53

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

Purpose

Antiseptic

Description

Alcohol 75%

Medication Information

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.

Purpose

Antiseptic

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.

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.

Description

Alcohol 75%

Use

For decreasing bacteria on the skin

Active Ingredient

Alcohol 75%

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

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.

Purpose

Antiseptic

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.

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.

Use

For decreasing bacteria on the skin

Active Ingredient

Alcohol 75%

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

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYL GLUCETH-10", "unii": "N0MWT4C7WH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER INTERPOLYMER TYPE A (55000 CPS)", "unii": "59TL3WG5CO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHLOROXYLENOL", "unii": "0F32U78V2Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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": "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"}

Additional Information

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