TOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR- benzalkonium chloride liquid 
TOPCO ASSOCIATES LLC

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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DRUG FACTS

ACTIVE INGREDIENT

BENZALKONIUM CHLORIDE 0.13%

PURPOSE

ANTIBACTERIAL

USES

HELPS ELIMINATE BACTERIA ON THE SKIN

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IN CASE OF CONTACT, RINSE THOROUGHLY WITH WATER

STOP USING THIS PRODUCT AND ASK A DOCTOR IF

IRRITATION AND REDNESS DEVELOPS AND LASTS

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

DIRECTIONS

USE ONLY TO REFILL A FOAMING HAND SOAP PUMP BOTTLE. APPLY ONTO DRY HANDS, WORK INTO A LATHER AND RINSE THOROUGHLY

OTHER INFORMATION

STORE AT ROOM TEMPERATURE

INACTIVE INGREDIENTS

WATER (AQUA), COCAMIDOPROPYL BETAINE, POLYSORBATE 20, GLYCERIN, FRAGRANCE (PARFUM), SODIUM CITRATE, XANTHAN GUM, POLYQUATERNIUM-7, DECYL GLUCOSIDE, TETRASODIUM EDTA, CITRIC ACID, CAMELLIA SINENSIS LEAF EXTRACT, ALOE BARBADENSIS LEAF JUICE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINOEN, YELLOW 10 (CI 47005), GREEN 3 (CI 42053)

LABEL COPY

IMAGE OF THE LABEL

TOPCARE  ANTIBACTERIAL FOAMING HAND FRESH PEAR
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-109
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
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-109-32946 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/28/2014
Labeler - TOPCO ASSOCIATES LLC (006935977)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(36800-109)

Revised: 7/2014
Document Id: 8527a69b-2da5-4b48-9b70-12bdbacd1322
Set id: 555e42f3-3638-4cff-ba22-22b197036339
Version: 1
Effective Time: 20140729
 
TOPCO ASSOCIATES LLC