level 1 health otc hand sanitizer

level 1 health otc hand sanitizer
SPL v4
SPL
SPL Set ID a4c95731-199e-1653-e053-2a95a90ae5fd
Route
topical
Published
Effective Date 2020-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (70 mL)
Inactive Ingredients
trolamine glycerin aloe vera leaf water isopropyl myristate .alpha.-tocopherol acetate, dl- carbomer interpolymer type a (55000 cps) peg-40 castor oil

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-05-12

Purpose

Antiseptic

Description

Ethyl 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, Glycerin, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Vitamine E Acetate, Carbomer, Propylene Glycol, Triethanolamine

Description

Ethyl Alcohol 70% v/v

Use

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 50566-9

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

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

Ethyl Alcohol 70% v/v

Package Label Principal Display Panel

LEVEL 1 HEALTH

Hand Sanitizer

Premium Moisturizing Gel

Unscented

WITH ALOE + VITAMIN E

70% Alcohol Antiseptic

XX FL OZ (XXX.X mL)

MADE IN USA

Distributed by

Level 1 Health

3636 S Geyer Rd. Suite 100

St. Louis, MO 63127

www.level1health.com | (314) 238-7348


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, Glycerin, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Vitamine E Acetate, Carbomer, Propylene Glycol, Triethanolamine

Use

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 50566-9 (50566-9)

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

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

Ethyl Alcohol 70% v/v

Package Label Principal Display Panel (Package Label - Principal Display Panel)

LEVEL 1 HEALTH

Hand Sanitizer

Premium Moisturizing Gel

Unscented

WITH ALOE + VITAMIN E

70% Alcohol Antiseptic

XX FL OZ (XXX.X mL)

MADE IN USA

Distributed by

Level 1 Health

3636 S Geyer Rd. Suite 100

St. Louis, MO 63127

www.level1health.com | (314) 238-7348


Advanced Ingredient Data


Raw Label Data

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