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CVS Pharmacy by Health-Tech, Inc.

Medically reviewed on January 26, 2018

Dosage form: spray
Ingredients: Benzalkonium Chloride .195mL in 15mL, Pramoxine Hydrochloride .15mL in 15mL
Labeler: Health-Tech, Inc.
NDC Code: 48871-000

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 Ingredients

Benzalkonium Chloride

Pramoxine Hydrochloride

Purpose

First Aid Antispetic

Topical Analgesic

Uses

First aid to help prevent infection and temporarily relieve pain or discomfort in minor cuts, scrapes and burns.

Warnings For external use only.

Do not useDo not use
  • in the eyes
  • overlarge areas of the body

Ask a doctor before use if you have:
  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if:
  • condition or symptoms get worse or last more than one week
  • symptoms clear up and occur again within a few days

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older:

  • clean the affected area
  • spray a small amount of this product on the area 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first
Children under 2 years of age: consult a doctor

Other information

Store at 200 to 250 C (680 to 770 F) Prior to initial use, prime pump by depressing multiple times.

Inactive Ingredients:

DI Water, Edetate Disodium, Propylene Glycol

MM1

MM3

CVS PHARMACY 
benzalkonium chloride, pramoxine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48871-000
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (benzalkonium ) Benzalkonium Chloride.195 mL  in 15 mL
Pramoxine Hydrochloride (Pramoxine ) Pramoxine Hydrochloride.15 mL  in 15 mL
Inactive Ingredients
Ingredient NameStrength
Edetate Disodium 
Propylene Glycol 
Water 
Packaging
#Item CodePackage Description
1NDC:48871-000-0012 CARTON (CARTON) in 1 BOX
16 BLISTER PACK (BLISTER) in 1 CARTON
11 BOTTLE, SPRAY (BOTTLE) in 1 BLISTER PACK
115 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart310.54501/19/2010
Labeler - Health-Tech, Inc. (084007889)
Establishment
NameAddressID/FEIOperations
Health-Tech, Inc.084007889manufacture

 
Health-Tech, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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