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

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75470-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75470-111-01	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020	09/22/2020

Labeler - Tecnoglobal Ph7, S.a. De C.v. (813006665)

Establishment
Name	Address	ID/FEI	Business Operations
Tecnoglobal Ph7, S.a. De C.v.		813006665	manufacture(75470-111)

Revised: 9/2020

Document Id: afee6201-8a8d-5846-e053-2a95a90adb53

34390-5

Set id: aee74ccf-3d82-14d5-e053-2a95a90a17b9

Version: 2

Effective Time: 20200922