HAND SANITIZER

HAND SANITIZER- alcohol gel
LOTUS ARTS CRAFTS LIMITED

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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HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78294-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	36.6 mL in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.3 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.1 mL in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.3 mL in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.2 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78294-002-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/22/2020
2	NDC:78294-002-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/22/2020
3	NDC:78294-002-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/22/2020
4	NDC:78294-002-04	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/22/2020
5	NDC:78294-002-05	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/22/2020
6	NDC:78294-002-06	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/22/2020
7	NDC:78294-002-07	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/22/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/22/2020

Labeler - LOTUS ARTS CRAFTS LIMITED (551468927)

Registrant - LOTUS ARTS CRAFTS LIMITED (551468927)

Name	Address	ID/FEI	Business Operations
Establishment
LOTUS ARTS CRAFTS LIMITED		551468927	manufacture(78294-002)