JMax Hand Sanitizer 75% (DEACTIVATED)

JMax Hand Sanitizer by

Drug Labeling and Warnings

JMax Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by JMAX California Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

JMAX HAND SANITIZER- alcohol solution 
JMAX HAND SANITIZER- alcohol spray 
JMAX California Co.

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JMax Hand Sanitizer 75% (DEACTIVATED)

Information

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active ingredient & Purpose

Antimicrobial

Active IngredientPurpose
Ethyl Alcohol 75% v/v.............................................................................Antimicrobial

Use

Jmax hand sanitizer gel helps reduce bacteria that potentially can 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 gel sanitizer on your palm and rub hands together covering entire hands until dry.
  • supervise children under 6 years of age when using this product to avoid swallowing.

14 Oz Spray

  • spary enough product to cover all surfaces
  • on hands rub together until dry
  • supervise children under 6 years of age when using this product to avoid swallowing

Other information

  • store between 59-86F (15-30F)
  • avoid freezing and excessive heat above 40C (104F)

14 oz Spray -

  • do not puncture or incenerate. Contents under pressure

Inactive ingredients

glycerin, hydrogen peroxide, water

14 Oz -

Inactive ingredients

glycerin, sodium benzoate, trolamine, water

Package Label - Principal Display Panel

Jmax Hand Sanitizer 75% Alcohol

100 mL NDC: 78917-100-03

180 mL NDC: 78917-100-05

236 mL NDC: 78917-100-08

450 mL NDC: 78917-100-13

480 mL NDC: 78917-100-14

JMAX

14 HS Spray

JMAX

JMAX HAND SANITIZER 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 78917-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 78917-100-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202012/31/2023
2NDC: 78917-100-05180 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/30/202012/31/2023
3NDC: 78917-100-08236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/202012/31/2023
4NDC: 78917-100-13450 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/04/202012/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00303/30/202002/13/2026
JMAX HAND SANITIZER 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 78917-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 78917-101-14480 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/30/202012/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00312/30/202002/13/2026
Labeler - JMAX California Co. (117139252)

Revised: 1/2023
Document Id: 066ecd70-163d-6242-e063-6394a90a42f8
Set id: a852da83-fcd4-6838-e053-2a95a90a9d1a
Version: 5
Effective Time: 20230101
 
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