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

Description

Ethyl Alcohol 62% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

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.

Warnings

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

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

Active Ingredient

Ethyl Alcohol 62% v/v

Other Information
  • Store between 15-30°C (59-86°F)
  • Avoid freezing and excessive heat beyond 40°C (104°F)
Package Labeling:

Inactive Ingredients

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

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

Purpose

Antiseptic

Uses(s)

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

Warnings

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

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.
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

Other Information (Other information)
  • Store between 15-30°C (59-86°F)
  • Avoid freezing and excessive heat beyond 40°C (104°F)
Package Labeling:

Inactive Ingredients (Inactive ingredients)

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

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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