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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73792-0005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73792-0005-1	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/24/2020
2	NDC:73792-0005-2	80 mL in 1 TUBE; Type 0: Not a Combination Product	07/24/2020
3	NDC:73792-0005-3	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/24/2020
4	NDC:73792-0005-4	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/24/2020
5	NDC:73792-0005-5	3780 mL in 1 CONTAINER; Type 0: Not a Combination Product	07/24/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/24/2020

Labeler - SAE HAN COSMETICS LTD (687835025)

Registrant - SAE HAN COSMETICS LTD (687835025)

Name	Address	ID/FEI	Business Operations
Establishment
SAE HAN COSMETICS LTD		687835025	manufacture(73792-0005)

Revised: 7/2020

Document Id: ab3509d6-2492-05ec-e053-2995a90a7577

Set id: 10fc0f79-5322-44fc-9190-967f4e5f42f6

Version: 1

Effective Time: 20200724

SAE HAN COSMETICS LTD