ANTIBACTERIAL SPRING RAIN- benzalkonium chloride liquid 
Brands International Corporation

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.

----------

Studio selection Antibacterial liquid hand soap- Spring rain

Active Ingredient - Benzalkonium Chloride - 0.13%

Purpose - Antibacterial

Use for handwashing to decrease bacteria on skin

for external use only - hands only

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if irritation or redness develops.

keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

Direction

* wet hands

* apply to hands

* scrub thoroughly

* rinse thoroughly

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Glycerin, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Vitamin E, Blue# 1, Yellow 5, Fragrance (Parfum)

4B41B1

ANTIBACTERIAL  SPRING RAIN
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-601
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
VITAMIN E POLYETHYLENE GLYCOL SUCCINATE (UNII: O03S90U1F2)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE SODIUM (UNII: MP1J8420LU)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50157-601-44443.6 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/06/2022
2NDC:50157-601-141480 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/14/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/06/2022
Labeler - Brands International Corporation (243748238)
Establishment
NameAddressID/FEIBusiness Operations
Brands International Corporation243748238manufacture(50157-601)

Revised: 11/2022
Document Id: ed76c513-2329-40ec-e053-2995a90a020d
Set id: e819ccb9-20f1-52fa-e053-2995a90a0b13
Version: 3
Effective Time: 20221114
 
Brands International Corporation