DRUG FACTS

DRUG FACTS

Drug Labeling and Warnings

Drug Details

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CVS PHARMACY REFRESHING- benzalkonium chloride liquid 
CVS PHARMACY

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. If contact occurs, rinse eyes 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

  • apply onto wet hands.
  • lather and rinse thoroughly.

Other information

store at room temperature.

Inactive ingredients

Water (Aqua), Cetrimonium Chloride, Glycerin, Lauramidopropylamine Oxide, Cocamide MEA, Sodium Chloride, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (CI 16035), Yellow 5 (CI 19140), Red 33 (CI 17200).

Label Copy

Image of the label

CVS PHARMACY  REFRESHING
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59779-325
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)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59779-325-561656 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/25/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/25/2017
Labeler - CVS PHARMACY (062312574)
Registrant - APOLLO HEALTH AND BEAUTY CARE INC. (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE INC.201901209manufacture(59779-325)

Revised: 1/2017
 
CVS PHARMACY


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