SPL v1
SPL
SPL Set ID d193a1fc-95ba-4979-bd10-6cbcf26044b0
Route
TOPICAL
Published
Effective Date 2020-09-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Aloe Vera Leaf Carbomer Homopolymer, Unspecified Type Diisopropylamine Glycerin Isopropyl Myristate Phenoxyethanol .alpha.-tocopherol Acetate D&c Yellow No. 10 Fd&c Yellow No. 5 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-15

Description

Alcohol 62% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol 62% v/v

Use

To sanitize hands without requiring water or a rinse – Kills 99.9% of most common bacteria in 15 seconds

Warnings

For external use only

Flammable

Do not use near heat or flame

Do not use

In children less than 2 months of age

On open skin wounds

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

Stop use and ask a doctor

if irritation or rash occurs.

They 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 atv 1-800-222-1222

Directions

Apply gel liberally to unsoiled hands and rub in thoroughly

Allow to dry without wiping or rinsing

Product Label

Active Ingredient

Alcohol 62% v/v

Other Information
  • Store at room temperature.
Inactive Ingredients

Water, Aloe barbadensis Leaf Juice, Carbomer, Diisopropylamine, Glycerin, Isopropyl Myristate, Fragrance, Phenoxyethanol, Tocopheryl Acetate, Yellow 10, Yellow 5, Blue 1.


Structured Label Content

Use

To sanitize hands without requiring water or a rinse – Kills 99.9% of most common bacteria in 15 seconds

Purpose

Antiseptic

Warnings

For external use only

Flammable

Do not use near heat or flame

Do not use

In children less than 2 months of age

On open skin wounds

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

Stop use and ask a doctor

if irritation or rash occurs.

They 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 atv 1-800-222-1222

Directions

Apply gel liberally to unsoiled hands and rub in thoroughly

Allow to dry without wiping or rinsing

Product Label (Product label)

Active Ingredient (Active ingredient)

Alcohol 62% v/v

Other Information (Other information)
  • Store at room temperature.
Inactive Ingredients (Inactive ingredients)

Water, Aloe barbadensis Leaf Juice, Carbomer, Diisopropylamine, Glycerin, Isopropyl Myristate, Fragrance, Phenoxyethanol, Tocopheryl Acetate, Yellow 10, Yellow 5, Blue 1.


Advanced Ingredient Data


Raw Label Data

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