ALPHA HANDRUB- ethyl alcohol liquid 
Alpha Cleantech Labs Inc

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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ALPHA HANDRUB ANTISEPTIC HAND SANITIZER

Drug Facts

Active ingredient

Ethyl alcohol 75 %

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)

• sealed cap

Inactive ingredients glycerin, hydrogen peroxide, water

Questions? +1-877-962-2636

You may also report serious side effects to this phone number.

Mon-Fri 9:00 AM - 5:00 PM

Manufactured for: Alpha Cleantech Labs Inc., Unit 111 – 20351 Duncan Way, Langley, British Columbia, V3A 7N3

COUNTRY OF ORIGIN : CANADA

Packaging

image description

ALPHA HANDRUB 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77959-075
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77959-075-6060 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/19/2020
2NDC:77959-075-50500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/19/2020
3NDC:77959-075-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/19/2020
4NDC:77959-075-0518927 mL in 1 CONTAINER; Type 0: Not a Combination Product05/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/19/2020
Labeler - Alpha Cleantech Labs Inc (204074603)
Establishment
NameAddressID/FEIBusiness Operations
Alpha Cleantech Labs Inc204074603manufacture(77959-075)

Revised: 5/2020
Document Id: 3e4116fa-76e8-40ec-80a8-5a533db5c3e5
Set id: c19aeb80-2f5b-401e-80ed-63886cfaafc1
Version: 1
Effective Time: 20200519
 
Alpha Cleantech Labs Inc