Kmart Corporation Antibiotic Cream + Pain Relief Drug Facts

Smart Sense antibiotic plus pain relief by

Drug Labeling and Warnings

Smart Sense antibiotic plus pain relief by is a Otc medication manufactured, distributed, or labeled by Kmart Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SMART SENSE ANTIBIOTIC PLUS PAIN RELIEF- neomycin, polymyxin b, pramoxine hcl cream 
Kmart Corporation

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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Kmart Corporation Antibiotic Cream + Pain Relief Drug Facts

Active ingredient (in each gram)

Neomycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B 10,000 units as polymyxin B sulfate

Pramoxine HCl 10 mg

Purpose

First aid antibiotic

External analgesic

Uses

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

• cuts
• scrapes
• burns

Warnings

For external use only.

Do not use

• if you are allergic to any of the ingredients
• in the eyes
• over large 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

• you need to use longer than 1 week
• condition persists or gets worse
• symptoms persist for more than 1 week, or clear up and occur again within a few days
• 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. (1-800-222-1222)

Directions

• adults and children 2 years of age or 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
• may be covered with a sterile bandage
• children under 2 years of age: ask a doctor

Other information

• store at 20o-25oC (68o-77oF)

Inactive ingredients

emulsifying wax, methylparaben, mineral oil, poloxamer 188, propylene glycol, purified water, white petrolatum

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENTS IN NEOSPORIN® + PAIN RELIEF

MAXIMUM STRENGTH

FIRST AID ANTIBIOTIC PAIN RELIEVING CREAM

antibiotic cream + pain relief

NEOMYCIN SULFATE & POLYMYXIN B SULFATE & PRAMOXINE HCl

HELPS SKIN HEAL TO LOOK HEALTHY

LONG LASTING INFECTION PROTECTION

NET WT 1 OZ (28 g)

SMART SENSE ANTIBIOTIC PLUS PAIN RELIEF 
neomycin, polymyxin b, pramoxine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49738-129
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
POLOXAMER 188 (UNII: LQA7B6G8JG)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49738-129-64	1 in 1 CARTON	09/20/2016	01/08/2019
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 final	part333B	09/20/2016	01/08/2019

Labeler - Kmart Corporation (008965873)

Revised: 12/2019

Document Id: 26e1bc31-a855-41c7-b9f6-07ed8299b8ab

34390-5

Set id: 971b1158-cb43-4de6-9ddf-4f14625f89ca

Version: 2

Effective Time: 20191217