winner alcohol

winner alcohol
SPL v1
SPL
SPL Set ID acadf278-0c42-3fa7-e053-2a95a90a279c
Route
topical
Published
Effective Date 2020-08-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
isopropyl alcohol (0.7 mL)
Inactive Ingredients
water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-05-28

Purpose

Antiseptic

Description

Isopropyl alcohol 70% v/v


Medication Information

Warnings

For external use only. Flammable. Keep away from heat or flame.

Purpose

Antiseptic

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
  • Store between 15-30C (59-86F) 
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients

purified water USP

Description

Isopropyl alcohol 70% v/v

Uses[s]

USE AS A RUBBING ALCOHOL ANTISEPTIC.

TOPICAL SOLLUTION 

Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Drug Facts

Package Labeling:

Active Ingredient[s]

Isopropyl alcohol 70% v/v

When Using This Product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water

Stop Use and Ask A Doctor

if irritation or rash occurs. These may be signs of a serious condition.

Keep Out of Reach of Children.

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


Structured Label Content

Warnings

For external use only. Flammable. Keep away from heat or flame.

Purpose

Antiseptic

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information (Other information)
  • Store between 15-30C (59-86F) 
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients (Inactive ingredients)

purified water USP

Uses[s]

USE AS A RUBBING ALCOHOL ANTISEPTIC.

TOPICAL SOLLUTION 

Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Drug Facts

Package Labeling:

Active Ingredient[s]

Isopropyl alcohol 70% v/v

When Using This Product (When using this product)

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water

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

if irritation or rash occurs. These may be signs of a serious condition.

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

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