ALTRUFUEL HAND SANITIZER- alcohol liquid 
Mad Dog Concepts, LLC

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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Altrufuel Hand Sanitizer

Drug Facts

Active Ingredient

Ethyl Alcohol 71%

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria on the skin

Warnings

Flammable. Keep from fire or flame.

For external use only

When using this proudct

Do not use in or near the eyes, ears or mouth. In case of contact, rinse thoroughly with water.

Stop use and ask a doctor 

if irritation, redness or rash appears and lasts.

Keep out of reach of children.

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

Directions

Put enough product in your palm to cover hands and rub hands together briskly until dry. 

Children should be supervised when using hand sanitizer.

Other Information

Inactive Ingredients

Water, Triethanolamine, Aloe, Barbadensis Gel, Glycol, Propylene, Glycerin, Carbomer

Package Labeling:(75421-000-00)

Label

Package Labeling:

Label2

ALTRUFUEL HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75421-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.71 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE (UNII: V5VD430YW9)  
ETHYLENE GLYCOL (UNII: FC72KVT52F)  
PROPYLENE (UNII: AUG1H506LY)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75421-000-0060 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/2020
2NDC:75421-000-01237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/25/2020
Labeler - Mad Dog Concepts, LLC (079733311)
Establishment
NameAddressID/FEIBusiness Operations
GENERAL ORGANICS INC187576251manufacture(75421-000)
Establishment
NameAddressID/FEIBusiness Operations
NINGBO MEINEKE Biotech Technology Co., Ltd.413126185manufacture(75421-000)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo BST Clean And Care Products Co., Ltd529352816manufacture(75421-000)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Gotdya Fine Chemical Co., Ltd.551470189manufacture(75421-000)
Establishment
NameAddressID/FEIBusiness Operations
Shantou Jiachun Biological Technology Co., Ltd.554528155manufacture(75421-000)

Revised: 8/2020
Document Id: ad3de8e1-69a3-430b-e053-2995a90a86af
Set id: e6166c7f-2cd2-40a0-85b4-37fdbbb751f7
Version: 6
Effective Time: 20200819
 
Mad Dog Concepts, LLC