NATUREPLEX ANTIBIOTIC PLUS PAIN, ITCH, SCAR RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream 
Natureplex LLC

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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Natureplex™ Antibiotic Ointment + Pain, Itch, Scar Relief
Topical

Drug Facts

Active ingredients (in each gram)Purpose
Bacitracin zinc 500 unitsFirst aid antibiotic
Neomycin sulfate 3.5 mgFirst aid antibiotic
Polymyxin B sulfate 10,000 unitsFirst aid antibiotic
Pramoxine hydrochloride 10 mgExternal analgesic

Uses

First aid to help prevent infection and temporary relief of pain or discomfort in minor:

Warnings

For external use only.

Not for prolonged use.

Do not use

  • in the eyes, nose, or over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

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

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

Adults and children 2 years old and older:

Children under 2 years old:

Other information

Inactive ingredients

gossypium herbaceum (cotton) seed oil, olea europaea (olive) fruit oil, petrolatum, sodium pyruvate, theobroma cacao (cocoa) seed butter, tocopheryl (vitamin E) acetate

Questions or comments?

866-323-0107 or www.natureplex.com

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Natureplex™

Antibiotic+Pain,
OINTMENT Itch, Scar
Relief

Bacitracin Zinc
Neomycin Sulfate
Polymyxin B Sulfate
Pramoxine HCl

NET WT 1 Oz (28g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
NATUREPLEX ANTIBIOTIC PLUS PAIN, ITCH, SCAR RELIEF 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-078
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
bacitracin zinc (UNII: 89Y4M234ES) (bacitracin - UNII:58H6RWO52I) bacitracin500 [iU]  in 1 g
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
COTTONSEED OIL (UNII: H3E878020N)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
petrolatum (UNII: 4T6H12BN9U)  
sodium pyruvate (UNII: POD38AIF08)  
cocoa butter (UNII: 512OYT1CRR)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67234-078-011 in 1 CARTON12/14/2021
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B12/14/2021
Labeler - Natureplex LLC (062808196)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(67234-078)

Revised: 12/2021
Document Id: 71cf511d-2bfa-4fe7-84bf-cde4bd5a510b
Set id: f0af8829-72fb-46b1-9328-6f4920710bb1
Version: 1
Effective Time: 20211216
 
Natureplex LLC