blitz Antibacterial Hand Cleansing Gel

blitz Antibacterial Hand Cleansing by

Drug Labeling and Warnings

blitz Antibacterial Hand Cleansing by is a Otc medication manufactured, distributed, or labeled by PROVABLE COSMETICS KIMYA URUNLERI SANAYI DIS TICARET LIMITED SIRKETI ANKARA SUBESI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BLITZ ANTIBACTERIAL HAND CLEANSING- alcohol gel 
PROVABLE COSMETICS KIMYA URUNLERI SANAYI DIS TICARET LIMITED SIRKETI ANKARA SUBESI

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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blitz Antibacterial Hand Cleansing Gel

Drug Facts

Active ingredient

Ethyl alcohol 70% v/v

Purpose

Antiseptic

Uses

• hand sanitizer to decrease bacteria on the skin
• recommended for repeated use
• for use when soap and water are not available

Warnings

Flammable, keep away from fire/flame
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

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

Directions

• wet hands thoroughly with product and allow to dry without wiping
• supervise children under 6 years of age when using this product to avoid swallowing

Other information

• store between 15-30°C (59-86°F)
• avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

carbomer, fragrance, glycerin, propylene glycol, triethanolamine, water

Questions?

+1-714-213-4608

You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM - 5:00 PM

Active Sanitizing
Provides Maximum Protection to You and Your Family
pure and clean hands

Manufactured by: Provable COSMETICS, KIMYA URUNLERI SAN DIS TIC LTD. STI., Icerenkoy Mah. Cihan SK. Eksioglu Sit A Blok
No. 33/A Atasehir, Istanbul, TURKEY, 06980

MADE IN TURKEY

Factory: Orhaniye Mah. 2051. Cad. No. 64 Kahraman Kazan Ankara / TURKEY

Distributed by A&A cosmetics Inc.

1325 N. Red Gum Street Suite, 17 Anaheim, CA 92806

www.aacosmeticus.com +1 714 213 4608

Packaging

BLITZ ANTIBACTERIAL HAND CLEANSING 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78436-305
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78436-305-15	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/05/2020	05/28/2022
2	NDC: 78436-305-16	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/05/2020	05/28/2022
3	NDC: 78436-305-17	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/05/2020	07/26/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/05/2020	05/28/2022

Labeler - PROVABLE COSMETICS KIMYA URUNLERI SANAYI DIS TICARET LIMITED SIRKETI ANKARA SUBESI (595840056)

Establishment
Name	Address	ID/FEI	Business Operations
PROVABLE COSMETICS KIMYA URUNLERI SANAYI DIS TICARET LIMITED SIRKETI ANKARA SUBESI		595840056	manufacture(78436-305)

Revised: 7/2021

Document Id: 5b53103d-515a-4a05-be9b-6305c77fa260

34390-5

Set id: 7a01d7f2-e6f7-4b57-be0a-d89e005496c6

Version: 4

Effective Time: 20210726

 

PROVABLE COSMETICS KIMYA URUNLERI SANAYI D