SPL v1
SPL
SPL Set ID 9578d3cd-936f-4f70-b6b8-9c82a08acfbd
Route
TOPICAL
Published
Effective Date 2020-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Glycerin Water Carbomer 934 Propylene Glycol Alpha-tocopherol Acetate Trolamine Aloe Vera Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-12

Description

NA

Purpose

Antispetic


Medication Information

Purpose

Antispetic

Description

NA

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease

For use when soap and water are not available

Section 42229-5

NA

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of serious condition

Section 50567-7

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

Section 51945-4

Warnings

For external use only

Flammable. Keep away from heat or flame

Do not use

  • on children less tha two months of age
  • on open skin wounds
Directions

Place enough product on hands to cover all surfaces. Rub hands untill dry

Supervise children under six years of age when using this product to avoid swallowing

Other Information

Store between 15-30 C (59 to 86F)

Avoid freezing and excessive heat above 40C (104F)

Active Ingredient(s)

Ethyl Alcohol 75% v/v

Inactive Ingredients

Water, triethanolamine, glycerin, propylene glycol, tocopheryl acetate, aloe barbadensis gel, carbomer, fragrance


Structured Label Content

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease

For use when soap and water are not available

Section 42229-5 (42229-5)

NA

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of serious condition

Section 50567-7 (50567-7)

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

Section 51945-4 (51945-4)

Purpose

Antispetic

Warnings

For external use only

Flammable. Keep away from heat or flame

Do not use

  • on children less tha two months of age
  • on open skin wounds
Directions

Place enough product on hands to cover all surfaces. Rub hands untill dry

Supervise children under six years of age when using this product to avoid swallowing

Other Information (Other information)

Store between 15-30 C (59 to 86F)

Avoid freezing and excessive heat above 40C (104F)

Active Ingredient(s)

Ethyl Alcohol 75% v/v

Inactive Ingredients (Inactive ingredients)

Water, triethanolamine, glycerin, propylene glycol, tocopheryl acetate, aloe barbadensis gel, carbomer, fragrance


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)