BENJAMINS HAND SANITIZER- hand sanitizer gel 
P. A BENJAMIN MANUFACTURING 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.

----------

Benjamins Hand Sanitizer

Active Ingredient(s)

Ethyl Alcohol 70% v/v.

Purpose

Purpose: Antiseptic/ Antibacterial Agent

Use

As a Hand Sanitizer to help reduce bacteria on skin.

Warnings

For external use only. Flammable.

Keep away from heat or flame.

Do not apply around eyes. In case of contact flush eyes with water.

KEEP OUT OF REACH OF CHILDREN.

Do not use

Do not apply around eyes. In case of contact flush eyes with water.

KEEP OUT OF THE REACH OF CHILDREN.

Children under 6 years of age should be supervised by an adult.

Directions

Place enough product in the palms to thoroughly cover hands. Rub hands together briskly until dry. Do not rinse. Children under 6 years of age should be supervised by an adult.

Other information

Inactive ingredients

Water, triethanolamine, carbomer, isopropyl myristate, glycerine, fragrance, Aloe Vera, Colour (Blue no.1)

Package Label - Principal Display Panel for Benjamins Hand Sanitizer 60 mL

Benjamins Hand Sanitizer 60 mL NDC: 82338-438-60 Benjamins Hand Sanitizer 60 mL

Package Label - Principal Display Panel for Benjamins Hand Sanitizer 240 mL

Benjamins Hand Sanitizer 240 mLBenjamins 240 mL Hand Sanitizer. NDC : 82338-438-24

Package Label - Principal Display Panel for Benjamins Hand Sanitizer 3.8 Lt

Benjamins Hand Sanitizer 3.8 Lt. NDC: 82338-438-3.8 Benjamins Hand Sanitizer 3.8 Lt

BENJAMINS HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82338-438
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL459.96 mL  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)  
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
DIHYDROMYRCENOL (UNII: 46L1B02ND9)  
GRAPEFRUIT OIL (UNII: YR377U58W9)  
2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)  
ETHYL LINALOOL (UNII: SF2JS9GF5T)  
3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
3-HEXENYL SALICYLATE, CIS- (UNII: C78Y9OR6YH)  
GLYCERIN (UNII: PDC6A3C0OX) 1.98 mL  in 1000 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 3.05 mL  in 1000 mL
WATER (UNII: 059QF0KO0R)  
CARBOMER 940 (UNII: 4Q93RCW27E) 3.6 g  in 1000 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.0002 g  in 1000 mL
TROLAMINE (UNII: 9O3K93S3TK) 4.82 mL  in 1000 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.116 g  in 1000 mL
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
ISOCYCLEMONE E (UNII: 1GD7ODM28Y)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LINALYL ACETATE (UNII: 5K47SSQ51G)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
Product Characteristics
Colorblue (Light Blue) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82338-438-6060 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/31/2021
2NDC:82338-438-24240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/31/2021
3NDC:82338-438-383800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/31/2021
Labeler - P. A BENJAMIN MANUFACTURING CO LTD (873219000)
Establishment
NameAddressID/FEIBusiness Operations
P. A BENJAMIN MANUFACTURING CO LTD873219000manufacture(82338-438)

Revised: 12/2021
Document Id: d09c5f8a-f12d-f15f-e053-2995a90ab2f5
Set id: d09cad87-15f6-1117-e053-2a95a90af292
Version: 1
Effective Time: 20211231
 
P. A BENJAMIN MANUFACTURING CO LTD