AWAKEN BY QUALITY CHOICE FOAMING HAND WASH SPRING SHOWERS- benzalkonium chloride soap 
Chain Drug MArketing Association 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.

----------

DRUG FACTS

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

helps eliminate bacterial on hands.

Warnings

For external use only.

When using this product

avoid contact with eyes. If contact occurs, 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

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, Propylene Glycol, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Blue1 (CI 42090), Ext. Violet 2 (CI 60730).

Questions or comments?

1-248-449-9300

Label Copy

Image of the label

AWAKEN BY QUALITY CHOICE FOAMING HAND WASH  SPRING SHOWERS
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-115
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)  
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-115-07222 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/18/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/18/2016
Labeler - Chain Drug MArketing Association Inc (011920774)
Registrant - Apollo Health and Beauty Care (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care201901209manufacture(63868-115)

Revised: 8/2016
Document Id: bcf05d86-2aaa-4bff-98da-bc7192d12290
Set id: eb5938de-5ccf-4c68-8315-7cca38b0687c
Version: 1
Effective Time: 20160822
 
Chain Drug MArketing Association Inc