90081-009 Groovy Grape Hand sanitizer

Hand sanitizer by

Drug Labeling and Warnings

Hand sanitizer by is a Otc medication manufactured, distributed, or labeled by FLTR, INC., Huizhou Baozi Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- fltr gel 
FLTR, INC.

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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90081-009
Groovy Grape Hand sanitizer

Active Ingredient

Eohyl Alcohol 75%

Purpose

Antimicrobial

Uses

Hand sanitizer to help reduce bacteria on skin

Warnings

Flammable. Keep away from fire or flame.
Harmful if swallowed.
For external use only.
CONTINUED NEXT PAGE

Do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.

WHEN USING THIS PRODUCT

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

Do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask aoctor if irritatioin or rash appears and lasts.

Stop use and ask aoctor if irritatioin or rash appears and lasts.

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

Directions

Directions: Place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry

Children under 6 years of age should be supervised when using this product

Other information

Store below 106°F (41°C)
May discolor certain fabrics or suriaces.

Inactive ingredients

water, caroomer, triethanolamine, fragrance

Package Label - Principal Display Panel

HAND SANITIZER 
fltr gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90081-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90081-009-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/27/2020	01/21/2021

Labeler - FLTR, INC. (117468331)

Establishment
Name	Address	ID/FEI	Business Operations
FLTR, INC.		117468331	label(90081-009)

Establishment
Name	Address	ID/FEI	Business Operations
Huizhou Baozi Biotechnology Co., Ltd.		419304583	manufacture(90081-009)

Revised: 1/2021

Document Id: b966b068-e3ae-703e-e053-2a95a90a153c

34390-5

Set id: b1762c42-ff27-7b2f-e053-2a95a90a24cd

Version: 5

Effective Time: 20210121

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