Loud Lock Hand Sanitizer by Ashh, Inc / Guangzhou Zanyu Cosmetics Co., Ltd. Loud Lock Hand Sanitizer

Drug Details [pdf]

LOUD LOCK HAND SANITIZER- alcohol gel
Ashh, 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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Loud Lock Hand Sanitizer

DRUG FACTS

Active Ingredient:

Alocohol 75% (V/V)

Purpose:

Antiseptic

USE:

Hand sanitizer to help reduce bacteria that can potentially cause disease. For use when soap and water are not available.

WARNINGS:

For external use on hands only.

Flammable, keep away from heat, fire or flame.

When using this product,

do not use in or near eyes, ears, and mouth. In case of contact with eyes, rinse throughly with water.

Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor

if skin irritation develops.

Keep out of reach of children

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

DIRECTIONS:

Place enough product on hands to cover all surfaces.
Rub hands together and allow to dry without wiping.
For children under 6, use only under adult supervision.
Not recommended for infants.
DO NOT USE on infants less than 2 months of age.

OTHER INFORMATION:

- Do not store above 104°F. Store between 59-86°F

- Avoid freezing and excessive heat

INACTIVE INGREDIENTS:

Water, Propylene Glycol, Carbomer, Triethanolamine, Allantoin, Aloe Barbaadensis Leaf Juice powder, Butylene Glycol, Artemisia Vulgaris Extract

Package Labeling:

Label

LOUD LOCK HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79077-007
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 79077-007-60	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2020	09/20/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/18/2020	09/20/2022

Labeler - Ashh, Inc (104550104)

Name	Address	ID/FEI	Business Operations
Establishment
Guangzhou Zanyu Cosmetics Co., Ltd.		420025960	manufacture(79077-007)

Revised: 9/2022

Document Id: e84461c6-7bd9-6d04-e053-2995a90a3470

Set id: 770a9609-7657-4f6e-a407-ec3c3f32652e

Version: 3

Effective Time: 20220909