HEARTY ADVANCED HAND SANITIZER- alcohol spray
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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73792-0006_Hearty Advanced Hand Sanitizer Spray

Active ingredient

Ethyl alcohol 70% v/v

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria on the skin.
Recommended for repeated use.

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

Keep out of reach of children.

Other information

Store betweem 68-77°F (20-25°C)

Directions

Spray directly on hands and rub thoroughly.

Inactive ingredients

Aloe Barbadensis Leaf Juice, Butylene Glycol, Camellia Sinensis Leaf Extract, Citrus Paradisi (Grapefruit) Fruit Extract, Glycerin, Lavandula Angustifolia (Lavender) Oil, Maltodextrin, Water

Product Label

HEARTY ADVANCED HAND SANITIZER
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73792-0006
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
LAVENDER OIL (UNII: ZBP1YXW0H8)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GRAPEFRUIT (UNII: O82C39RR8C)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73792-0006-1	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/24/2020	12/06/2021
2	NDC:73792-0006-2	300 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/24/2020	12/06/2021
3	NDC:73792-0006-3	500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/24/2020	12/06/2021
4	NDC:73792-0006-4	1000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/24/2020	12/06/2021
5	NDC:73792-0006-5	3780 mL in 1 CONTAINER; Type 0: Not a Combination Product	07/24/2020	12/06/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/24/2020	12/06/2021

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(73792-0006)

Revised: 12/2021

Document Id: d2857d9d-42cf-ccf1-e053-2995a90a9fab

Set id: cc48914a-efde-4d99-ba58-c9c11cb1a942

Version: 2

Effective Time: 20211206

SAE HAN COSMETICS LTD