HAND SANITIZER- alcohol gel 
Nanomateriales, 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.

----------

ZANILAST+ GEL 70% ALCOHOL

Active Ingredients

Ethyl Alcohol 70%

Purpose: Antiseptic

Use

For hand washing to decrease bacteria on the skin.

Warnings

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

Do not use

Stop use and ask a doctor if irritation and redness develop. Condition persists 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

Other information

Inactive ingredients

Carbomer, glycerin, fragrance, triethanolamine, water, zinc oxide, zinc pyrithione

200000 mL NDC 69912-009-06

200L

60 mL NDC 69912-009-05

60mL

500 mL NDC 69912-009-03

500mL

250 mL NDC 69912-009-04

250mL

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69912-009
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
ZINC OXIDE (UNII: SOI2LOH54Z)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
GLYCERIN (UNII: PDC6A3C0OX)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
PYRITHIONE ZINC (UNII: R953O2RHZ5)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69912-009-06200000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
2NDC:69912-009-0560 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
3NDC:69912-009-03500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
4NDC:69912-009-04250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/10/2020
Labeler - Nanomateriales, S.A. de C.V. (812756920)
Registrant - Nanomateriales, S.A. de C.V. (812756920)
Establishment
NameAddressID/FEIBusiness Operations
Nanomateriales, S.A. de C.V.812756920manufacture(69912-009) , pack(69912-009) , label(69912-009)

Revised: 7/2020
Document Id: aa1d95fe-0d7b-927a-e053-2a95a90af6f1
Set id: aa19e8fd-302e-fe93-e053-2995a90aa870
Version: 2
Effective Time: 20200710
 
Nanomateriales, S.A. de C.V.