Hand Sanitizer

ADVANCED PURELL- ethyl alcohol liquid
Freshorize 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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Hand Sanitizer

Ethyl Alcohol 70%

Antimicrobial

Hand sanitizer to help reduce bacteria on the skin.

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.

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

Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

Water, Isopropyl Alcohol, Isopropyl Alcohol, PEG-12 Dimethicone, Caprylyl Glycol, Glycerin, Propylene Glycol, Isopropyl Myristate, Tocopheryl Acetate, Fragrance.

Label

ADVANCED PURELL
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52305-940
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52305-940-10	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/24/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/24/2020

Labeler - Freshorize Ltd (424168503)

Registrant - Derma Care Research Labs, LLC (116817470)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		036424534	manufacture(52305-940)

Name	Address	ID/FEI	Business Operations
Establishment
Derma Care Research Labs, LLC		116817470	repack(52305-940)