doctors kline & green board certified dermatologist hand sanitizer antiseptic

doctors kline & green board certified dermatologist hand sanitizer antiseptic
SPL v2
SPL
SPL Set ID bc7e624c-0ee4-b6b5-e053-2a95a90abf8d
Route
topical
Published
Effective Date 2021-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (62 mL)
Inactive Ingredients
water 1,1-difluoroethane isobutane propane

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-02-09

Purpose

Antiseptic

Description

Ethyl Alcohol 62% v/v


Medication Information

Warnings

For external use only. Extermely flammable, do not use near heat or flame or while smoking.

Purpose

Antiseptic

Directions
  • Hold can upside down and dispense into palm. 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 15-30°C (59-86°F)
  • Avoid freezing and excessive heat beyond 40°C (104°F)
Inactive Ingredients

Purified Water, Hydrofluorocarbon 152a; Isobutane; Emulsifying Wax NF; Propane

Description

Ethyl Alcohol 62% v/v

Uses(s)

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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

Active Ingredient

Ethyl Alcohol 62% v/v

Package Labeling:

When Using This Product
  • keep out of eyes, ears, and mouth
  • In case of contact with eyes, rinse eyes thoroughly with water.
  • Do not puncture or incinerate
  • Contents under pressure
  • Do not expose to heat or store at temperature above 120°F (49°C)
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. Extermely flammable, do not use near heat or flame or while smoking.

Purpose

Antiseptic

Directions
  • Hold can upside down and dispense into palm. 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 15-30°C (59-86°F)
  • Avoid freezing and excessive heat beyond 40°C (104°F)
Inactive Ingredients (Inactive ingredients)

Purified Water, Hydrofluorocarbon 152a; Isobutane; Emulsifying Wax NF; Propane

Uses(s)

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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

Active Ingredient (Active ingredient)

Ethyl Alcohol 62% v/v

Package Labeling:

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.
  • Do not puncture or incinerate
  • Contents under pressure
  • Do not expose to heat or store at temperature above 120°F (49°C)
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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