INSTAFRESH SANITIZING HAND WIPES

INSTAFRESH SANITIZING HAND WIPES by

Drug Labeling and Warnings

INSTAFRESH SANITIZING HAND WIPES by is a Otc medication manufactured, distributed, or labeled by COSMO KIMYA KOZMETIK TEKSTIL SANAYI VE TICARET LIMITED SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INSTAFRESH SANITIZING HAND WIPES- benzalkonium chloride swab 
COSMO KIMYA KOZMETIK TEKSTIL SANAYI VE TICARET LIMITED SIRKETI

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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INSTAFRESH SANITIZING HAND WIPES

Drug Facts

Active Ingredients

Benzalkonium Chloride 0.125%

Purpose

Antimicrobial.

Use

decreases bacteria on skin.

Warnings

For external use only.

Do not use if you are allergic to any of the ingredients.

When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 2 years and over:

• apply to hands.
• allow skin to dry without wiping.

Children under 2 years: ask a doctor before use.

Inactive Ingredients

Water (Aqua), Ethanol, Decyl Glucoside, Glycerin, Aloe Vera Extract, Dexpanthenol, Fragrance (Parfum).

KILLS 99.9% OF GERMS

• FRESH SCENT
• ALOE VERA
• PROVITAMIN B5
• GLYCERIN

Instafresh Sanitizing Hand Wipes kill 99.9% of germs and wipe away dirt. Specially formulated with glycerin, aloe vera leaf extract and provitamin b5 to protect and moisturize your skin.

DIRECTIONS TO OPEN PACKAGE

Flip open dispensing cap. Remove and discard sealing foil. Locate wipe at center of roll and pull through small opening in lid. To avoid injury do not push finger through opening. For best results dispense wipes at an angle. Snap lid cap shut to retain moisture after use.

STORAGE AND DISPOSAL: DO NOT FLUSH. Dispose of wipe in trash after use. Do not reuse or refill this container; discard in trash.

KEEP OUT OF REACH OF CHILDREN

CAUTION: SEE BACK PANEL FOR ADDITIONAL PRECAUTIONARY STATEMENTS.

NOT A BABY WIPE

Manufactured in Turkey for

Clinol Chemicals LLC

8 The Green STE B DE 19901

info@clinolchem.com

www.instafreshwipes.com

Packaging

INSTAFRESH SANITIZING HAND WIPES 
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81388-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.125 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DEXPANTHENOL (UNII: 1O6C93RI7Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81388-003-01	40 in 1 CANISTER	01/12/2021
1		5.09 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 81388-003-02	80 in 1 CANISTER	01/12/2021
2		5.09 mL in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC: 81388-003-03	100 in 1 CANISTER	01/12/2021
3		5.09 mL in 1 PACKAGE; Type 0: Not a Combination Product
4	NDC: 81388-003-04	120 in 1 CANISTER	01/12/2021
4		5.09 mL in 1 PACKAGE; Type 0: Not a Combination Product
5	NDC: 81388-003-05	150 in 1 CANISTER	01/12/2021
5		5.09 mL in 1 PACKAGE; Type 0: Not a Combination Product
6	NDC: 81388-003-06	350 in 1 PAIL	01/12/2021
6		5.09 mL in 1 PACKAGE; Type 0: Not a Combination Product
7	NDC: 81388-003-07	450 in 1 PAIL	01/12/2021
7		5.09 mL in 1 PACKAGE; Type 0: Not a Combination Product
8	NDC: 81388-003-08	72 in 1 PACKET	01/12/2021
8		3.05 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/12/2021

Labeler - COSMO KIMYA KOZMETIK TEKSTIL SANAYI VE TICARET LIMITED SIRKETI (354641685)

Establishment
Name	Address	ID/FEI	Business Operations
COSMO KIMYA KOZMETIK TEKSTIL SANAYI VE TICARET LIMITED SIRKETI		354641685	manufacture(81388-003)

Revised: 1/2021

Document Id: 920de798-f418-45ea-84aa-2b810a7e1073

34390-5

Set id: be3c22d1-1faa-42d8-b1c0-d7d72972d375

Version: 1

Effective Time: 20210112

 

COSMO KIMYA KOZMETIK T