CAREONE  ANTIBIOTIC PLUS PAIN RELIEF- neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream 
American Sales Company

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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CAREONE™
Antibiotic Plus Pain Relief

Drug Facts

Active ingredients (each gram contains)Purpose
Neomycin sulfate 3.5 mgFirst aid antibiotic
Polymyxin B sulfate 10,000 unitsFirst aid antibiotic
Pramoxine hydrochloride 10 mgTopical analgesic

Uses

first aid to help prevent infection and for the temporary relief of pain or discomfort in

Warnings

For external use only

Do not use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week

Ask a doctor before use

  • on deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

  • condition gets worse
  • condition persists for more than 7 days
  • condition clears up and occurs again within a few days
  • a rash or other allergic reaction develops

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

Inactive ingredients

emulsifying wax, methylparaben, mineral oil, propylene glycol, purified water, white petrolatum

DISTRIBUTED BY
AMERICAN SALES COMPANY
4201 WALDEN AVENUE
LANCASTER, NY 14086

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

CAREONE™

MAXIMUM STRENGTH
ANTIBIOTIC CREAM + PAIN RELIEF
Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

FIRST AID ANTIBIOTIC / PAIN RELIEVING CREAM

NET WT 1/2 oz

(14.2 g)

Principal Display Panel - 14.2 g Tube Carton
CAREONE   ANTIBIOTIC PLUS PAIN RELIEF
neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-076
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin3.5 mg  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B10000 [iU]  in 1 g
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
methylparaben (UNII: A2I8C7HI9T)  
mineral oil (UNII: T5L8T28FGP)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-076-011 in 1 CARTON
114.2 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B03/21/2012
Labeler - American Sales Company (809183973)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(41520-076)

Revised: 1/2013
Document Id: eb308349-f997-4748-808d-2cdd0edec392
Set id: b5156e69-0e52-4961-a5e7-e36001fdd3e4
Version: 1
Effective Time: 20130115
 
American Sales Company