COMPLETED 8-18-2020 75662-008 BROOKSTONE ADVANCED HAND SANITIZER/ALCOHOL

BROOKSTONE ADVANCED HAND SANITIZER by

Drug Labeling and Warnings

BROOKSTONE ADVANCED HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Ningbo Chenxing Daily Necessities Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BROOKSTONE ADVANCED HAND SANITIZER- alcohol gel 
Ningbo Chenxing Daily Necessities Co., 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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COMPLETED 8-18-2020 75662-008 BROOKSTONE ADVANCED HAND SANITIZER/ALCOHOL

Active Ingredient(s)

Ethyl Alcohol 75% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial, Hand Sanitizer

Use

• Decreases bacteria on the skin that could cause diseases.
• Recommended for repeated use.

Warnings

• For external use on hand only.
• Flammable. Keep away from flame or fire.

Do not use

• in children less than 2 months of age
• on open skin wounds

• When using this product keep out of eyes, In case of contact with eyes, flush thoroughly with water.
• Do not ingest or inhale.
• Avoid contact with broken skin.

Stop use and ask a doctor if redness & irritation develop or if condition persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• Spread products on hands thoroughly & allow to dry, do not wipe off.
• For children under 6, use only with adult supervision.
• Not recommended for use with infants.

Other information

• Do not store above 105℉（40.6℃）.
• May discolor some fabrics.
• Harmfull to plastics & wood finishes.

Inactive ingredients

purified water USP, Glycerin, Peg-7 Glyceryl Cocoate, Carbomer, Triethanolamine, Fragrance, May Contain Red 33(CI17200).

Package Label - Principal Display Panel

BROOKSTONE ADVANCED HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75662-008
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
GLYCERIN (UNII: PDC6A3C0OX)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
TROLAMINE (UNII: 9O3K93S3TK)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75662-008-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/17/2020	08/18/2020
2	NDC: 75662-008-02	29.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/17/2020	08/18/2020
3	NDC: 75662-008-03	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/17/2020	08/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/17/2020	08/18/2020

Labeler - Ningbo Chenxing Daily Necessities Co., Ltd. (554531297)

Registrant - Ningbo Chenxing Daily Necessities Co., Ltd. (554531297)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Chenxing Daily Necessities Co., Ltd.		554531297	manufacture(75662-008)

Revised: 8/2020

Document Id: ad204476-0ae0-999f-e053-2995a90a34a4

34390-5

Set id: ad09a589-8e3c-b723-e053-2995a90ae0ab

Version: 2

Effective Time: 20200818

 

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