GIANT EAGLE WHITE TEA FOAMING REFILL- benzalkonium chloride liquid 
Apollo Health and Beauty Care

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 thoroughly with water.

Stop use and ask a 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

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

GIANT EAGLE WHITE TEA FOAMING REFILL 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-102
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)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63148-102-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/27/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/27/2016
Labeler - Apollo Health and Beauty Care (201901209)
Registrant - Apollo Health and Beauty Care (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care201901209manufacture(63148-102)

Revised: 10/2016
Document Id: f0ba03d3-dc1f-4e31-89c4-c77dafacf03c
Set id: ee12ea49-db63-4fbf-84f8-d49ecc274b31
Version: 1
Effective Time: 20161031
 
Apollo Health and Beauty Care