SOLGREAT ALCOHOL-FREE HAND SANITIZER- benzalkonium chloride gel 
PANATURAL USA, 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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SolGreat Alcohol-Free Hand Sanitizer

Active lngredient  

Benzalkonium Chloride

Purpose 

Antibacterial

Uses

Warnings  


For external use only.

Flammable. Keep away from fire or flame.

Do not apply around eyes. Do not use in ears & mouth.

When using this product, avoid contact with eyes. In case of contact flush eyes with water.

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

Directions

Inactive ingredients 

BUTYLENE GLYCOL, CITRIC ACID, DIAZOLIDINYL UREA, HYDROXYETHYCELLULOSE, PEG-40 HYDROGENATE CASTOR OIL, PROPYLENE GLYCOL, WATER.

Keep out of reach of children

Children must be supervised in use of this product

Products Label-237mL SolGreat Alcohol-Free Hand Sanitizer

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Product Label- 500mL SolGreat Alcohol-Free Hand Sanitizer

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SOLGREAT ALCOHOL-FREE HAND SANITIZER 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73913-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73913-004-01237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2020
2NDC:73913-004-02500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/23/2020
Labeler - PANATURAL USA, INC. (029572239)

Revised: 4/2020
Document Id: 9aeb2181-41d9-4adb-9563-6f52d020b9f0
Set id: db7d0307-d754-428c-b483-eefd1e2ea9d4
Version: 2
Effective Time: 20200422
 
PANATURAL USA, INC.