73792-0005_Hearty Advanced Hand Sanitizer Gel

Hearty Advanced Hand Sanitizer gel by

Drug Labeling and Warnings

Hearty Advanced Hand Sanitizer gel by is a Otc medication manufactured, distributed, or labeled by SAE HAN COSMETICS LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEARTY ADVANCED HAND SANITIZER GEL- alcohol gel 
SAE HAN COSMETICS LTD

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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73792-0005_Hearty Advanced Hand Sanitizer Gel

Ethyl Alcohol 70% v/v

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Butylene Glycol, Camellia Sinensis Leaf Extract, Carbomer, Glycerin, Lavandula Angustifolia (Lavender) Oil, Maltodextrin, Water

Antiseptic

KEEP OUT OF REACH OF THE CHILDREN

Health care personnel hand urb to help reduce bacteria that potentially can cause disease

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Apply a sufficient amount on hands and rub thoroughly until dry.

label

HEARTY ADVANCED HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73792-0005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73792-0005-130 mL in 1 BOTTLE; Type 0: Not a Combination Product07/24/202012/06/2021
2NDC: 73792-0005-280 mL in 1 TUBE; Type 0: Not a Combination Product07/24/202012/06/2021
3NDC: 73792-0005-3300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/24/202012/06/2021
4NDC: 73792-0005-4500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/24/202012/06/2021
5NDC: 73792-0005-53780 mL in 1 CONTAINER; Type 0: Not a Combination Product07/24/202012/06/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/24/202012/06/2021
Labeler - SAE HAN COSMETICS LTD (687835025)
Registrant - SAE HAN COSMETICS LTD (687835025)
Establishment
NameAddressID/FEIBusiness Operations
SAE HAN COSMETICS LTD687835025manufacture(73792-0005)

Revised: 12/2021
 

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