Freshmaker Antiseptic Hand Wipes

Freshmaker Antiseptic Hand Wipes
SPL v1
SPL
SPL Set ID 1cbcd01d-604e-4916-9660-82a6b5fe05e5
Route
TOPICAL
Published
Effective Date 2020-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Benzoic Acid Citric Acid Monohydrate Cocamidopropyl Betaine Dehydroacetic Acid Glycerin Peg-7 Glyceryl Cocoate Phenoxyethanol Polysorbate 20 Propylene Glycol Edetate Sodium Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-01

Description

Benzalkonium chloride 0.13%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium chloride 0.13%

Uses
  • hand wipes to decrease bacteria on the skin
  • recommended for repeated use
  • for use when soap and water are not available
Section 42229-5

ANTISEPTIC AGENT

BENZALKONIUM CHLORIDE

Manufactured by : Fulya Kozmetik Islak Mendil Iml. ve Paz.Ltd.Sti.

Kirac Osmangazi Kucuk Ayazma Street No:17

34522, Esenyurt/ISTANBUL/TURKEY

P: +90 212 689 28 28 Fax: +90 212 689 82 28

Made in TURKEY

Web: http://www.fulyakozmetik.com

e-mail: [email protected]

Lot No:

Expiry:

You may also report any serious side effects to 

PO BOX 328, Wood Ridge, NJ 07075-328

Warnings

For external use only

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

  • irritation and redness develop
  • condition persists for more than 72 hours
Packaging

Directions
  • open resealable label. Pull out wipes. Close resealable label to prevent drying out
  • wipe hands thoroughly with product and allow to dry
  • dispose the wipe after use
  • supervise children under 6 years of age when using this product to avoid swallowing 
  • do not flush
drug Facts

Active Ingredient

Benzalkonium chloride 0.13%

Other Information
  • store between 15-30˚C(59-86˚F)
  • avoid freezing and excessive heat above 40˚C(104˚F)
Inactive Ingredients

benzoic acid, citric acid, cocamidopropyl betaine, dehydroacetic acid, fragrance, glycerin, PEG-7 glyceryl cocoate, phenoxyethanol, polysorbate 20, propylene glycol, tetrasodium EDTA, water

keep Out of Reach of Children.

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


Structured Label Content

Uses
  • hand wipes to decrease bacteria on the skin
  • recommended for repeated use
  • for use when soap and water are not available
Section 42229-5 (42229-5)

ANTISEPTIC AGENT

BENZALKONIUM CHLORIDE

Manufactured by : Fulya Kozmetik Islak Mendil Iml. ve Paz.Ltd.Sti.

Kirac Osmangazi Kucuk Ayazma Street No:17

34522, Esenyurt/ISTANBUL/TURKEY

P: +90 212 689 28 28 Fax: +90 212 689 82 28

Made in TURKEY

Web: http://www.fulyakozmetik.com

e-mail: [email protected]

Lot No:

Expiry:

You may also report any serious side effects to 

PO BOX 328, Wood Ridge, NJ 07075-328

Purpose

Antiseptic

Warnings

For external use only

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

  • irritation and redness develop
  • condition persists for more than 72 hours
Packaging

Directions
  • open resealable label. Pull out wipes. Close resealable label to prevent drying out
  • wipe hands thoroughly with product and allow to dry
  • dispose the wipe after use
  • supervise children under 6 years of age when using this product to avoid swallowing 
  • do not flush
drug Facts (Drug Facts)

Active Ingredient (Active ingredient)

Benzalkonium chloride 0.13%

Other Information (Other information)
  • store between 15-30˚C(59-86˚F)
  • avoid freezing and excessive heat above 40˚C(104˚F)
Inactive Ingredients

benzoic acid, citric acid, cocamidopropyl betaine, dehydroacetic acid, fragrance, glycerin, PEG-7 glyceryl cocoate, phenoxyethanol, polysorbate 20, propylene glycol, tetrasodium EDTA, water

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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