Hand Sanitizer by Tecnoglobal Ph7, S.a. De C.v. Whataburger 75470-111-01

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Tecnoglobal Ph7, S.a. De C.v.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol liquid 
Tecnoglobal Ph7, 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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Whataburger 75470-111-01

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

Hand Sanitizer to help 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

  • 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

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

Inactive ingredients

water, PEG-12 Dimethicone, Glycerin, Carbomer, Propylene Glycol, Aminomethyl Propanol, Phenoxythanol/Iodopynyl Butylcarbamate, Tetrasodium EDTA, Ext. Violet 2 (CI 607730), Alo Barbadensis Leaf Juice.

Package Label - Principal Display Panel

2000 mL NDC: 75470-111-01

2000mL

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 75470-111
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
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
WATER (UNII: 059QF0KO0R)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
EDETATE SODIUM (UNII: MP1J8420LU)  
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75470-111-012000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/202009/22/2020
Labeler - Tecnoglobal Ph7, S.a. De C.v. (813006665)
Establishment
NameAddressID/FEIBusiness Operations
Tecnoglobal Ph7, S.a. De C.v.813006665manufacture(75470-111)

Revised: 9/2020
 
Tecnoglobal Ph7, S.a. De C.v.