SaniZER, Hand Sanitizer Spray

SaniZER Hand Sanitizer by

Drug Labeling and Warnings

SaniZER Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Zermat Internacional S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SANIZER HAND SANITIZER- alcohol spray 
Zermat Internacional S.A. de C.V.

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SaniZER, Hand Sanitizer Spray

Drug Facts

Active ingredient[s]

Alcohol 80% v/v

Purpose

Antiseptic

Use[s]:

Hand sanitizer to help reduce bacteria which could potentially cause disease. For use when soap and water are not available.

Warnings:

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

Do not use

In children less than 2 months of age. On open skin wounds

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

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

Directions

  • Apply 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

  • Store between 15-30°C (59-86°F)
  • Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients:

Blue No.1 C.I.42090., Fragrance, Propylene Glycol, Purified water.

Package Labeling:247ml

Bottle2

Package Labeling:60ml

60ml

SANIZER HAND SANITIZER 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 15828-199
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 15828-199-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product07/17/202005/30/2024
2NDC: 15828-199-02247 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/202005/30/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)07/10/202005/30/2024
Labeler - Zermat Internacional S.A. de C.V. (812820712)

Revised: 6/2024
Document Id: 1a12b237-4dbc-0712-e063-6394a90abf16
Set id: 643ceec0-f82e-428b-b8e7-20580be20304
Version: 6
Effective Time: 20240604