SPL v1
SPL
SPL Set ID b0e32307-5608-bd4c-e053-2a95a90a0985
Route
TOPICAL
Published
Effective Date 2020-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 mL)
Inactive Ingredients
.alpha.-tocopherol Acetate Glycerin Hydrogen Peroxide Water Aloe Vera Leaf

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: Benzalkonium Chloride ( Glycerol Hydrogen peroxide Sterile distilled water or boiled cold water. Aloe vera leaf extract Vitamin E

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

The sanitizer wipes is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients: Benzalkonium Chloride ( Glycerol Hydrogen peroxide Sterile distilled water or boiled cold water. Aloe vera leaf extract Vitamin E

Use

Antiseptic wipes to help reduce bacteria that potentially can cause disease. 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:

  • Benzalkonium Chloride (
  • Glycerol
  • Hydrogen peroxide
  • Sterile distilled water or boiled cold water.
  • Aloe vera leaf extract
  • Vitamin E

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
  • To dispense, lift cover, remove seal, pull center sheet from roll, twist to a point and feed through dispenser holde in cover. Keep lid closed to prevent moisture loss.
  • Open and unfold wipe
  • Thoroughly wipe hands, fingers and wrists. Be sure to use the entire wipe. Allow to dry.
  • For dirty hands, use first wipe to clean hands, then discard wipe, sanitize with the second wipe.
  • Discard after single use
  • 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
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients

water(aqua), glycerin, hydrogen peroxide, Aloe Barbadensis, Tocopheryl Acetate Vitamin E

Package Label Principal Display Panel

80ct NDC: 76665-013-80


Structured Label Content

Use

Antiseptic wipes to help reduce bacteria that potentially can cause disease. 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:

  • Benzalkonium Chloride (
  • Glycerol
  • Hydrogen peroxide
  • Sterile distilled water or boiled cold water.
  • Aloe vera leaf extract
  • Vitamin E

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

Antiseptic

Warnings

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

Directions
  • To dispense, lift cover, remove seal, pull center sheet from roll, twist to a point and feed through dispenser holde in cover. Keep lid closed to prevent moisture loss.
  • Open and unfold wipe
  • Thoroughly wipe hands, fingers and wrists. Be sure to use the entire wipe. Allow to dry.
  • For dirty hands, use first wipe to clean hands, then discard wipe, sanitize with the second wipe.
  • Discard after single use
  • 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
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

water(aqua), glycerin, hydrogen peroxide, Aloe Barbadensis, Tocopheryl Acetate Vitamin E

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

80ct NDC: 76665-013-80


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)