GIANT EAGLE COCONUT WATER FOAMING- benalkonium chloride liquid 
Apollo Health and Beauty Care Inc.

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

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

Inactive ingredients

Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Fruit Extract, Bambusa Vulgaris Extract, Propylene Glycol, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

Label Copy

Image of the label

GIANT EAGLE COCONUT WATER FOAMING 
benalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-842
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)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
COCONUT (UNII: 3RT3536DHY)  
BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SULISOBENZONE (UNII: 1W6L629B4K)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63148-842-08222 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/23/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/23/2017
Labeler - Apollo Health and Beauty Care Inc. (201901209)
Registrant - Apollo Health and Beauty Care Inc. (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care Inc.201901209manufacture(63148-842)

Revised: 5/2017
Document Id: ffd9ef69-ec59-4313-8218-b453b5aa7c7e
Set id: 4cba6960-9208-411e-ad58-f602f3461106
Version: 1
Effective Time: 20170524
 
Apollo Health and Beauty Care Inc.