HEALTHY ACCENTS ANTIBACTERIAL WHITE TEA- benzalkonium chloride liquid
DZA BRANDS 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 HANDS

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

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

STOP USE AND ASK DOCTOR IF

IRRITATION OR 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

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

LABEL COPY

IMAGE OF THE LABEL

HEALTHY ACCENTS ANTIBACTERIAL WHITE TEA
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55316-102
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55316-102-08	221 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	02/03/2015

Labeler - DZA BRANDS LLC (090322194)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture(55316-102)