HAND SANITIZER- alcohol gel 
REALITY PHARMA, 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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HAND SANITIZER GEL

DOSAGE

Place enough product on hands to cover all surfaces. Rub hands together until dry.

INACTIVE INGREDIENTS

Inactive ingredients Water (Aqua), Glycerin, Carbomer, Triethanolamine

DIRECTIONS

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE

PURPOSE ANTIMICROBIAL

WARNINGS

Warnings

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

ACTIVE INGREDIENT

Active ingredient. Ethyl Alcohol 70% v/v

STOP USE ASK A DOCTOR

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

PRINCIPAL DISPLAY

LABEL 125 ml FINALLABEL 250 mlLABLE 1000 mLLABEL 500 mL

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78525-2000
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
TRIETHANOLAMINE CAPROYL GLUTAMATE (UNII: 0F2FO57253) 0.002 mL  in 1 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.002 mL  in 1 mL
WATER (UNII: 059QF0KO0R) 0.2585 mL  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.0375 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78525-2000-2125 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
2NDC:78525-2000-3250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
3NDC:78525-2000-4500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
4NDC:78525-2000-51000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/02/2020
Labeler - REALITY PHARMA, S.A. DE C.V. (951578646)
Registrant - REALITY PHARMA, S.A. DE C.V. (951578646)
Establishment
NameAddressID/FEIBusiness Operations
REALITY PHARMA, S.A. DE C.V.951578646manufacture(78525-2000)

Revised: 6/2020
Document Id: a716238a-e60c-6614-e053-2a95a90a95a1
Set id: a716238a-e60b-6614-e053-2a95a90a95a1
Version: 1
Effective Time: 20200602
 
REALITY PHARMA, S.A. DE C.V.