SPL v3
SPL
SPL Set ID aa95e99f-5c17-c394-e053-2995a90a6bf9
Route
TOPICAL
Published
Effective Date 2020-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 L)
Inactive Ingredients
Carbomer Homopolymer Type C Glycerin Water Isopropyl Myristate Trolamine .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-01 Until 2027-02-19

Description

Alcohol 70% v/v.


Medication Information

Description

Alcohol 70% v/v.

Use(s)

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

Section 50565-1

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

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.



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

Section 51945-4

Section 55105-1

Purpose: Antiseptic

Warnings

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

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.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient

Alcohol 70% v/v.

Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients

water, glycerin, isopropyl myristate, carbomer, tocopheryl acetate, triethanolamine


Structured Label Content

Use(s)

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

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 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.



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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Antiseptic

Warnings

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

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

Alcohol 70% v/v.

Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients (Inactive ingredients)

water, glycerin, isopropyl myristate, carbomer, tocopheryl acetate, triethanolamine


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)