HAND SANITIZER- alcohol gel 
FARMIRAL, 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 AND ADMINISTRATION

Directions

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

INACTIVE INGREDIENTS

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

INDICATIONS

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.

ACTIVE INGREDIENT

Active ingredient. Ethyl Alcohol 70% v/v…

PURPOSE

Purpose Antmicrobial

WARNINGS AND PRECAUTIONS

Store below 110°F (43°C)

Children under 6 years of age should be supervised when using.

WARNING

Warnings

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

STOP USE

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

PACKAGE LABEL

LABEL HAND SANITIZER 250 mLLABEL HAND SANITIZER 500 mLLABEL 1000 mL ENGLISH

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78814-6000
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
GLYCERIN (UNII: PDC6A3C0OX) 0.025 mL  in 1 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.01 mL  in 1 mL
WATER (UNII: 059QF0KO0R) 0.205 mL  in 1 mL
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) 0.06 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78814-6000-1250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/2020
2NDC:78814-6000-2500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/2020
3NDC:78814-6000-31000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/08/2020
Labeler - FARMIRAL, S.A. DE C.V. (951579167)
Registrant - FARMIRAL, S.A. DE C.V. (951579167)
Establishment
NameAddressID/FEIBusiness Operations
FARMIRAL, S.A. DE C.V.951579167manufacture(78814-6000)

Revised: 6/2020
Document Id: a7b3b837-a6eb-9c69-e053-2a95a90a6b66
Set id: a78d252d-f819-c57c-e053-2a95a90a2e0a
Version: 3
Effective Time: 20200610
 
FARMIRAL, S.A. DE C.V.