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

Natureplex Antibiotic Plus Pain, Itch, Scar Relief by

Drug Labeling and Warnings

Natureplex Antibiotic Plus Pain, Itch, Scar Relief by is a Otc medication manufactured, distributed, or labeled by Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each gram)	Purpose
Bacitracin zinc 500 units	First aid antibiotic
Neomycin sulfate 3.5 mg	First aid antibiotic
Polymyxin B sulfate 10,000 units	First aid antibiotic
Pramoxine hydrochloride 10 mg	External analgesic

Uses

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

• cuts
• scrapes
• burns

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:

• clean the affected area
• apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
• the affected area may be covered with a sterile bandage

Children under 2 years old:

• ask a doctor

Other information

• store at 15 to 30°C (59 to 86°F)
• Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

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)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67234-078
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
bacitracin zinc (UNII: 89Y4M234ES) (bacitracin - UNII:58H6RWO52I)	bacitracin	500 [iU]  in 1 g
neomycin sulfate (UNII: 057Y626693) (neomycin - UNII:I16QD7X297)	neomycin	3.5 mg  in 1 g
polymyxin b sulfate (UNII: 19371312D4) (polymyxin b - UNII:J2VZ07J96K)	polymyxin b	10000 [iU]  in 1 g
pramoxine hydrochloride (UNII: 88AYB867L5) (pramoxine - UNII:068X84E056)	pramoxine hydrochloride	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67234-078-01	1 in 1 CARTON	12/14/2021
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M004	12/14/2021

Labeler - Natureplex LLC (062808196)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(67234-078)