OTC Medication Information: SolGreat Antibacterial Handwash

SOLGREAT ANTIBACTERIAL HANDWASH- benzalkonium chloride liquid
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

• for handwashing to decrease bacteria on the skin.

Warnings For external use only.

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

Stop use and ask a doctor if irritation and redness develop.

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• place enough product into your palms, wet as needed.
• lather vigorously for at least 20 seconds.
• wash skin, rinse and dry thoroughly.

Inactive ingredients

Cetrimonium Chloride, Cocamide Methyl MEA, Lauramine Oxide, Methylchoroisothiazolinone, Methylisothiazolinone, Parfum (Fragrance), Propanediol, Sodium Chloride, Tocopheryl Acetate, FD&C Yellow No. 5, FD&C Red No. 4, Water.

Product Label 237mL SolGreat Antibacterial Hand Soap

Product Label — 500mL SolGreat Antibacterial Hand Soap

SOLGREAT ANTIBACTERIAL HANDWASH benzalkonium chloride liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73913-003 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 COCOYL METHYL MONOETHANOLAMINE LAURAMINE OXIDE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE PROPANEDIOL SODIUM CHLORIDE .ALPHA.-TOCOPHEROL ACETATE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73913-003-01 237 mL in 1 BOTTLE None 2 NDC:73913-003-02 500 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 03/23/2020

Labeler — PANATURAL USA, INC. (029572239)

Establishment
Name	Address	ID/FEI	Operations
Hefei Yatai Daily-Use Chemical Industry Co., Ltd		654641724	manufacture (73913-003)

Revised: 03/2020 PANATURAL USA, INC.