HAND SANITIZER- alcohol gel 
Risan Cosmetics S.A. de C.V.

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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Ethyl Alcohol 70% v/v

Antiseptic

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

For external use only. Flammable. Keep away from fire or flame.

keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid

contact with broken skin. Do not inhale or ingest.

and ask a doctor if irritation or rash occurs.

  • Condition persists for more than 72 hours.

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

Avoid freezing and excessive heat above 40C (104F). May discolor some fabrics. Harmful to wood finishes and plastics.

Water, Carbomer, Triethanolamine.

Call: Risan Cosmetics +52 462 606 6070

Manufactured by Risan Cosmetics S.A. de C.V. Victorino de las Fuentes 487 Col. Barrio Nuevo P.C. 36530 Irapuato, Guanajuato, Mexico. Made in Mexico.

Hand Sanitizer

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75668-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL700 L  in 1000 L
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 (UNII: 4Q93RCW27E) 6 L  in 1000 L
TROLAMINE (UNII: 9O3K93S3TK) 10 L  in 1000 L
WATER (UNII: 059QF0KO0R) 284 L  in 1000 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75668-200-011000 L in 1 CONTAINER; Type 0: Not a Combination Product05/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/11/2020
Labeler - Risan Cosmetics S.A. de C.V. (812814244)

Revised: 5/2020
Document Id: a565484c-9ad6-4dad-e053-2995a90adc57
Set id: a565484c-9ad5-4dad-e053-2995a90adc57
Version: 1
Effective Time: 20200511
 
Risan Cosmetics S.A. de C.V.