SPL v1
SPL
SPL Set ID b168f919-040a-44f0-e053-2a95a90a8c51
Route
TOPICAL
Published
Effective Date 2020-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (0.3 mL)
Inactive Ingredients
Eucalyptus Smithii Oil Glycerin Hydrogen Peroxide Carbomer Interpolymer Type A (55000 Cps) Aloe Vera Leaf Aminomethylpropanol Water .alpha.-tocopherol Acetate, D-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-17

Description

The sanitizer wipes is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients: Alcohol (Isopropyl alcohol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerol Hydrogen peroxide Sterile distilled water or boiled cold water. (27.465%) Fragrance (Parfum) Aloe vera leaf extract Tocopheryl Acetate (Vitamin E) Aminomethyl Propanol

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

The sanitizer wipes is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients: Alcohol (Isopropyl alcohol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerol Hydrogen peroxide Sterile distilled water or boiled cold water. (27.465%) Fragrance (Parfum) Aloe vera leaf extract Tocopheryl Acetate (Vitamin E) Aminomethyl Propanol

Use

Hand Sanitizer to help reduce bacteria on the skin. For use when soap and water are not available.

Section 42229-5

The sanitizer wipes is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

  • Alcohol (Isopropyl alcohol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerol
  • Hydrogen peroxide
  • Sterile distilled water or boiled cold water. (27.465%)
  • Fragrance (Parfum)
  • Aloe vera leaf extract
  • Tocopheryl Acetate (Vitamin E)
  • Aminomethyl Propanol

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.



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.

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 age 6 when using this product to avoid swallowing
Do Not Use
  • on children less than 2 months of age
  • on open skin wounds
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients

water(aqua), glycerin, aloe vera barbadensis (aloe vera) leaf extract, tocopheryl acetate (Vitamine E), hydrogen peroxide, Aminomethyl Propanol, fragrance(parfum)

Package Label Principal Display Panel

3875 mL NDC: 76665-011-01

473 mL NDC: 76665-011-16

236mL NDC: 76665-011-08


Structured Label Content

Use

Hand Sanitizer to help reduce bacteria on the skin. For use when soap and water are not available.

Section 42229-5 (42229-5)

The sanitizer wipes is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

  • Alcohol (Isopropyl alcohol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerol
  • Hydrogen peroxide
  • Sterile distilled water or boiled cold water. (27.465%)
  • Fragrance (Parfum)
  • Aloe vera leaf extract
  • Tocopheryl Acetate (Vitamin E)
  • Aminomethyl Propanol

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.



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.

Purpose

Antibacterial

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 age 6 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
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

water(aqua), glycerin, aloe vera barbadensis (aloe vera) leaf extract, tocopheryl acetate (Vitamine E), hydrogen peroxide, Aminomethyl Propanol, fragrance(parfum)

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

3875 mL NDC: 76665-011-01

473 mL NDC: 76665-011-16

236mL NDC: 76665-011-08


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)