Germ Shield Hand Sanitizer

Germ Shield Hand Sanitizer by

Drug Labeling and Warnings

Germ Shield Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Tamara International Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GERM SHIELD HAND SANITIZER- alcohol gel 
Tamara International Inc.

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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Germ Shield Hand Sanitizer

Drug Facts

Active ingredient(V/V)

Ethyl Alcohol 80%

Purpose

Antiseptic skin cleanser

Inactive ingredients

Aqua (Water)  Glycerin  Polyquaternium-37  Hydrolyzed Jojoba Esters

Uses

  • Antiseptic(skin) cleanser
  • Effective in destorying (harmful) bacteria to provide antiseptic cleansing 
  • For personal hand hygiene to help prevent the spread of bacteria

Warnings

  • For External use only
  • Highly flammable. Keep away from heat source or flame

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water

Stop use and ask health care professional

If irritation develops.

Keep out of reach of children.

If swallowed, call a poison control centre or get medical help right away.

Directions

  • Rub thoroughly into hands for at least 30 seconds. Allow to dry
  • Adults and children over 2 years
  • For Occasional and personal domestic use
  • Supervise Children when they use this product

Storage Condition

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

Package Labeling:500ml

Bottle

Package Labeling:1000ml

Bottle2

Package Labeling:5000ml

Bottle3

GERM SHIELD HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80299-009
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
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80299-009-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/202009/30/2023
2NDC: 80299-009-021000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/202009/30/2023
3NDC: 80299-009-035000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/202009/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/01/202009/30/2023
Labeler - Tamara International Inc. (204195754)

Revised: 9/2023
Document Id: 068623f9-0f84-50bc-e063-6294a90aea00
Set id: f1a260f9-e181-4d74-af24-7e376af7da6b
Version: 4
Effective Time: 20230929