TOPCARE ANTIBACTERIAL FOAMING HAND FRESH WATER- benzalkonium chloride liquid

TOPCARE by

Drug Labeling and Warnings

TOPCARE by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC, APOLLO HEALTH AND BEAUTY CARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION AND REDNESS DEVELOP AND LAST

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

DIRECTIONS

PUMP ONTO DRY HANDS. WORK INTO A RICH FOAMY LATHER, RINSE THOROUGHLY AND DRY

OTHER INFORMATION

STORE AT ROOM TEMPERATURE

INACTIVE INGREDIENTS

WATER (AQUA), COCAMIDOPROPYL BETAINE, GLYCERIN, DECYL GLUCOSIDE, ALOE BARBADENSIS LEAF JUICE, CAMELLIA SINENSIS LEAF EXTRACT, FRAGRANCE (PARFUM), POLYQUATERNIUM-7, XANTHAN GUM, TETRASODIUM EDTA, POLYSORBATE 20, SODIUM CITRATE, CITRIC ACID, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1 (CI 42090), EXT. VIOLET 2 (CI 60730)

LABEL COPY

INGREDIENTS AND APPEARANCE

TOPCARE  ANTIBACTERIAL FOAMING HAND FRESH WATER
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE SODIUM (UNII: MP1J8420LU)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-114-08	222 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/24/2014

Labeler - TOPCO ASSOCIATES LLC (006935977)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture(36800-114)