CRISP PEAR ANTIBACTERIAL FOAMING HAND- benzalkonium chloride soap 
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 ingredients

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

For hand washing to decrease bacteria on the skin.

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 for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Store at room temperature.

Inactive ingredients

Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Polyquaternium-7, Xanthan Gum, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Green 3 (CI 42053), Yellow 10 (Ci 47005).

Label Copy

Image of the label

CRISP PEAR ANTIBACTERIAL FOAMING HAND 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-112
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)  
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)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63148-112-07222 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/29/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/29/2017
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(63148-112)

Revised: 3/2017
Document Id: 86ab573e-1674-41f3-8ec8-c97a98f12da2
Set id: bcc35b0f-d108-42c8-976e-d6a8cff1995d
Version: 1
Effective Time: 20170330
 
Apollo Health and Beauty Care Inc.