antimicrobial wipes

antimicrobial wipes
SPL v1
SPL
SPL Set ID b3f3a44e-20d2-bc95-e053-2995a90aac06
Route
topical
Published
Effective Date 2020-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (97.14 g)
Inactive Ingredients
water phenoxyethanol glycerin propylene glycol peg-60 hydrogenated castor oil hydrogen peroxide aloe vera leaf .alpha.-tocopherol acetate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph not final active Since 2020-11-12

Purpose

Antimicrobial

Description

Benzalkonium Chloride 0.13%


Medication Information

Warnings

For external use only.

Uses

Antimicrobial Wipes are used to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Purpose

Antimicrobial

Directions
  • To dispense, lift cover, remove seal, pull center sheet from roll, twist to a point and feed through dispenser hole 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 2 years of age when using this product to avoid swallowing
Other Information
  • Store between 15-30ºC (59-86°F)
  • Avoid freezing and excessive heat above 40ºC(104°F)
Inactive Ingredients

Water, Glycerin, Aloe barbadensis (aloe vera) leaf extract, Hydrogen Peroxide, Tocopheryl Acetate (Vitamin E), PEG-60 Hydrogenated Castor Oil, Propylene Glycol, Phenoxyethanol

Description

Benzalkonium Chloride 0.13%

Do Not Use
  • in children less than 2 years of age, do not use as baby wipe.
  • on open skin wounds
Active Ingredients

Benzalkonium Chloride 0.13%

Stop Use and Ask Doctor

If irritation or rash occurs. These may be signs of a serious condition.

When Using This Product

Keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Label and Product Picture

80 wipes in 1 canister, NDC: 76523-094-80

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings

For external use only.

Uses

Antimicrobial Wipes are used to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Purpose

Antimicrobial

Directions
  • To dispense, lift cover, remove seal, pull center sheet from roll, twist to a point and feed through dispenser hole 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 2 years of age when using this product to avoid swallowing
Other Information (Other information)
  • Store between 15-30ºC (59-86°F)
  • Avoid freezing and excessive heat above 40ºC(104°F)
Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Aloe barbadensis (aloe vera) leaf extract, Hydrogen Peroxide, Tocopheryl Acetate (Vitamin E), PEG-60 Hydrogenated Castor Oil, Propylene Glycol, Phenoxyethanol

Do Not Use (Do not Use)
  • in children less than 2 years of age, do not use as baby wipe.
  • on open skin wounds
Active Ingredients

Benzalkonium Chloride 0.13%

Stop Use and Ask Doctor (Stop use and ask doctor)

If irritation or rash occurs. These may be signs of a serious condition.

When Using This Product (When using this product)

Keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Label and Product Picture (Label and product picture)

80 wipes in 1 canister, NDC: 76523-094-80

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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