CVS PHARMACY - benzalkonium chloride, pramoxine hydrochloride spray 
Health-Tech, 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

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 use

Do not use

Ask a doctor before use if you have:

Stop use and ask a doctor if:

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:

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

MM1bottle label jpeg

MM3master shipping carton

CVS PHARMACY 
benzalkonium chloride, pramoxine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48871-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride.195 mL  in 15 mL
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride.15 mL  in 15 mL
Inactive Ingredients
Ingredient NameStrength
Edetate Disodium (UNII: 7FLD91C86K)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48871-000-0012 in 1 BOX
16 in 1 CARTON
11 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/FEIBusiness Operations
Health-Tech, Inc.084007889manufacture

Revised: 1/2010
Document Id: acecdf01-dc1a-4204-8bda-134abf496421
Set id: 60cc1ea1-f063-4988-bfe9-d18cfe323d92
Version: 1
Effective Time: 20100126
 
Health-Tech, Inc.