BINASFRI SANITIZER Clean Hand Care Mint by Mesopharm Co., Ltd.

BINASFRI SANITIZER Clean Hand Care Mint by

Drug Labeling and Warnings

BINASFRI SANITIZER Clean Hand Care Mint by is a Otc medication manufactured, distributed, or labeled by Mesopharm Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BINASFRI SANITIZER CLEAN HAND CARE ROSE- hand sanitizer gel 
BINASFRI SANITIZER CLEAN HAND CARE LEMON- hand sanitizer gel 
BINASFRI SANITIZER CLEAN HAND CARE MINT- hand sanitizer gel 
Mesopharm 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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This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Glycerol (1.45% v/v).
Hydrogen peroxide (0.125% v/v).
Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Ethly Alcohol 70% v/v

Purpose

Antiseptic

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

Warnings

For external use only. Flammable. Keep away from heat or flame.

When using this product

keep out of eyes, ears, and mouth.

In case of contact with eye, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or rash occrus.

These may be signs of a serious condition.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

Place enough product on hands to cover all surfaces.

Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-30°C (59-86 °F)

Avoid freezing and excessive heat above 40 °C (104 °F)

For external use only.

Flammable.

Keep away from heat or flame.

Alcohol, Aloe Vera Gel, Alpha-Isomethyl lonone, Benzophenone-9, Benzyl Salicylate, Citric Acid, Citronellol, Coix Seed Extract, Eugenol, Fragrance, Genraniol, Glycerin, Ipomoea Batatas Root Extract, Mulberry Root Extract, Purified water USP, Starch

Alcohol, Aloe Vera Gel, Benzophenone-9, Coix Seed Extract, Fragrance, Glycerin, Limonene, Mulberry Root Extract, Purified water USP, Sodium Citrate, Spriulina Platensis Extract, Trehalose

Alcohol, Aloe Vera Gel, Butylene Glycol, Citral, Coix Sed Extract, Coptis Japonica Extract, Fragrance, Geraniol, Glycerin, Limonene, Linalool, Mulberry Root Extract Purified water USP

Package Label-Principal Display Panel

BINASFREE SANITIZER Clean Hand Care Lemon Label

Package Label Principal Display Panel

BINASFRI SANITIZER Clean Hand Care Rose Label

Package Label Principal Display Panel

BINASFRI SANITIZER Clean Hand Care Mint

Package Label Principal Display Panel

BINASFRI SANITIZER Clean Hand Care Lemon Package

Package Label Principal Display Panel

BINASFRI SANITIZER Clean Hand Care Rose Package

Package Label Principal Display Panel

BINASFRI SANITIZER Clean Hand Care Mint Package

BINASFRI SANITIZER CLEAN HAND CARE ROSE 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 77098-3000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE (UNII: V5VD430YW9)  
GLYCERIN (UNII: PDC6A3C0OX)  
EUGENOL (UNII: 3T8H1794QW)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
MORUS ALBA ROOT (UNII: CST1G9BZGD)  
GERANIOL (UNII: L837108USY)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
STARCH, CORN (UNII: O8232NY3SJ)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 77098-3000-41 in 1 BOX05/08/2021
1NDC: 77098-3000-538 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/08/202112/23/2021
BINASFRI SANITIZER CLEAN HAND CARE LEMON 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 77098-1000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE (UNII: V5VD430YW9)  
GLYCERIN (UNII: PDC6A3C0OX)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
MORUS ALBA ROOT (UNII: CST1G9BZGD)  
GERANIOL (UNII: L837108USY)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
COPTIS JAPONICA WHOLE (UNII: 8BO3NHJ535)  
CITRAL (UNII: T7EU0O9VPP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 77098-1000-81 in 1 BOX05/08/2021
1NDC: 77098-1000-938 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/08/202112/23/2021
BINASFRI SANITIZER CLEAN HAND CARE MINT 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 77098-2000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE (UNII: V5VD430YW9)  
GLYCERIN (UNII: PDC6A3C0OX)  
BENZOPHENONE-9 (UNII: 7925W14T4L)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
MORUS ALBA ROOT (UNII: CST1G9BZGD)  
GERANIOL (UNII: L837108USY)  
SPIRULINA PLATENSIS (UNII: 9L3TIH1UUE)  
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
TREHALOSE DIHYDRATE (UNII: 7YIN7J07X4)  
FRAGRANCE MINT ORC2000774 (UNII: G7LK3FFB99)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 77098-2000-61 in 1 BOX05/08/2021
1NDC: 77098-2000-738 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/08/202112/23/2021
Labeler - Mesopharm Co., Ltd. (695708527)
Establishment
NameAddressID/FEIBusiness Operations
Mesopharm Co., Ltd.695708527manufacture(77098-3000, 77098-2000, 77098-1000)

Revised: 5/2021
Document Id: c1c363bd-5ad4-3811-e053-2a95a90a44b2
Set id: c1c36bfe-3766-cf80-e053-2995a90a5462
Version: 3
Effective Time: 20210508
 
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