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TopCare Antibacterial Foaming Hand Complete

Medically reviewed on April 18, 2017

Dosage form: liquid
Ingredients: BENZALKONIUM CHLORIDE 1.3mg in 1mL
Labeler: TopCo Associates LLC
NDC Code: 36800-124

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.

Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

Helps eliminate bacteria on hands.

Warnings

For external use only.

When using this product

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

Stop use and ask a doctor if

irritation and redness develops or lasts.

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

pump onto hands. Work into a rich foamy lather, rinse thoroughly and dry.

Other information

store at room temperature.

Inactive ingredients

Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Red 4 (CI 14700), Yellow 5 (CI 19140).

Label Copy

TOPCARE  ANTIBACTERIAL FOAMING HAND COMPLETE
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-124
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
COCAMIDOPROPYL BETAINE 
POLYSORBATE 20 
GLYCERIN 
DECYL GLUCOSIDE 
HYDROXYETHYL CELLULOSE (5000 CPS AT 1%) 
ALOE VERA LEAF 
GREEN TEA LEAF 
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) 
EDETATE SODIUM 
SODIUM CITRATE 
CITRIC ACID MONOHYDRATE 
SULISOBENZONE 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
FD&C RED NO. 4 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:36800-124-07222 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/31/2017
Labeler - TopCo Associates LLC (006935977)
Registrant - Apollo Health and Beauty Care Inc. (201901209)
Establishment
NameAddressID/FEIOperations
Apollo Health and Beauty Care Inc.201901209manufacture(36800-124)

 
TopCo Associates LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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