SANIKIT- hand sanitizer gel gel 
Renopac, 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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ACTIVE INGREDIENT - OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% (w/w)

PURPOSE - OTC - PURPOSE SECTION

Antiseptic

USES - INDICATIONS AND USAGE SECTION

Health care personal hand rub to help reduce bacteria that potentially can cause disease

WARNINGS - WARNINGS SECTIONS

For external use only.

Flammable.

Kepp away from heat or flame.

DO NOT USE - DO NOT USE SECTION

WHEN USING THIS PRODUCT - WHEN USING SECTION

Keep out of eyes, ears, and mouth.

In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE AND ASK A DOCTOR - STOP USE SECTION

If irritation or rash occur. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS - DOSAGE AND ADMINISTRATION SECTION

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

Supervise children under 6 years of age when using this product to avoid swallowing.

OTHER INFORMATION - STORAGE AND HANDLING SECTION

Store between 15-30ºC (59-86ºF)

Avoid freezing and excessive heat above 40ºC (104ºF)

INACTIVE INGREDIENTS - INACTIVE INGREDIENT SECTION

Purified water, carbomer, glycerin, triethanolamine.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

SANIKIT LABEL SANIKIT 5g NDC - 79067-004-01

SANIKIT 
hand sanitizer gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79067-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79067-004-015 mL in 1 POUCH; Type 0: Not a Combination Product09/20/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/20/2023
Labeler - Renopac, S.A. de C.V. (811085489)
Establishment
NameAddressID/FEIBusiness Operations
Renopac, S.A. de C.V.811085489manufacture(79067-004) , pack(79067-004) , label(79067-004)

Revised: 7/2023
Document Id: 003e98b4-c97d-4464-e063-6294a90adc35
Set id: 003e98b4-c97c-4464-e063-6294a90adc35
Version: 1
Effective Time: 20230712
 
Renopac, S.A. de C.V.