HAND SANITIZER- alcohol gel 
Quimi Clean

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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Hand Sanitizer

Drug Facts

Active ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Uses

to decrease bacteria on the skin that could cause disease recommended for repeated use.

Warnings

For external use only: hands

Flammable, keep away from fire or flame

When using this product 

keep out of eyes, In case of contact with eyes, flush thoroughly with water./ avoid contact with broken skin/ do not inhale or ingest.

Stop use and ask a doctor

of irritation and redness develop/ condition persosts 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 thorouughly with product and allow to dry without wiping / for children under 6, use only under adult supervision/ not recommended for infacts

Other Information

do not store above 105 F / may discolor some fabrics / harmful to wood finishes and plastics

Inactive Ingredients

Water, glycerin/caprylate carbopol, vitamin E,Water, glycerin, caprate, tocopheryl acetate, acrylates/C10-30 alkyl acrylates crosspolymer

Package Labeling:240ml

Bottle

Package Labeling:400ml

Bottle2

Package Labeling:580ml

Bottle3

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78153-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CAPRYLOYL/CAPROYL METHYL GLUCAMIDE (UNII: 0451R360HR)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78153-000-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
2NDC:78153-000-13400 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
3NDC:78153-000-19580 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/15/2020
Labeler - Quimi Clean (951578018)
Establishment
NameAddressID/FEIBusiness Operations
Quimi Clean951578018manufacture(78153-000)

Revised: 5/2020
Document Id: a689e7b9-6a3e-7b83-e053-2a95a90a6614
Set id: 8f346e43-3210-448f-a39e-5882bb5e9397
Version: 1
Effective Time: 20200526
 
Quimi Clean