OTC Medication Information: SolGreat Alcohol-Free Foaming Hand Sanitizer

SOLGREAT ALCOHOL-FREE FOAMING HAND SANITIZER- benzalkonium chloride spray
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.

Active lngredient

Benzalkonium Chloride

Purpose

Antibacterial

Uses

• hand sanitizer to help reduce bacteria on the skin that could cause disease.
• recommended for repeated use.

Warnings

For external use only.

When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water,

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

Directions

• place enough product in your palm to thoroughly cover your hands.
• rub hands together until dry.
• children under 6 years of age should be supervised when using this product.

Inactive Ingredients

cetrimonium chloride citric acid, cocamidopropyl betaine, cocamidopropylamine oxide, glycerin, propylene glycol, tocopheryl acetate, water.

Keep out of reach of children.

Children must be supervised in use of this product.

Other information

To prevent discoloration, avoid contact with clothing.

Product Label — 60 mL SolGreat Alcohol-Free Hand Sanitizer Spray

Product Label- 354mL SolGreat Alcohol-Free Foaming Hand Sanitizer

SOLGREAT ALCOHOL-FREE FOAMING HAND SANITIZER benzalkonium chloride spray

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73913-002 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL

Inactive Ingredients Ingredient Name Strength CETRIMONIUM CHLORIDE CITRIC ACID MONOHYDRATE COCAMIDOPROPYL BETAINE COCAMIDOPROPYLAMINE OXIDE GLYCERIN PROPYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73913-002-01 60 mL in 1 BOTTLE None 2 NDC:73913-002-02 354 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/28/2020

Labeler — PANATURAL USA, INC. (029572239)

Establishment
Name	Address	ID/FEI	Operations
Hefei Yatai Daily-Use Chemical Industry Co., Ltd		654641724	manufacture (73913-002)

Revised: 03/2020 PANATURAL USA, INC.