Double Antibiotic + Pain Relief - Freds

Drug Labeling and Warnings

Drug Details [pdf]

DOUBLE ANTIBIOTIC PLUS PAIN RELIEF MAXIMUM STRENGTH- neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride cream 
Fred's 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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Double Antibiotic + Pain Relief - Freds

Drug Facts

Active ingredients (in each gram)

Neomycin 3.5 mg
Polymyxin B sulfate, USP 10,000 units
Pramoxine hydrochloride, USP 10 mg

Purposes

First aid antibiotic/Pain reliever

Uses

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

• minor cuts
• scrapes
• burns

Warnings

For external use only

Allergy alert:

• do not use if allergic to any of the ingredients

Do not use

• 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

When using this product

• do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

• condition persists or gets worse
• symptoms last for more than 7 days or clear up and occur again within a few days
• a rash or other allergic reaction occurs

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:

• clean 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 59°-86°F (15°-30°C).
• Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

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

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.

PRINCIPAL DISPLAY PANEL

fred’s Pharmacy

NDC: 55315-822-34

RELIEVES PAIN FROM CUTS, SCRAPES & BURNS WHILE PREVENTING INFECTION 

MAXIMUM STRENGTH
DOUBLE ANTIBIOTIC + PAIN RELIEF
(NEOMYCIN SULFATE-POLYMYXIN B SULFATE-PRAMOXINE HCL)

FIRST AID ANTIBIOTIC / PAIN RELIEVING CREAM

NET WT ½ OZ (14g)

Compare To The Active Ingredients In:
*Neosporin® + Pain Relief

double antibiotic

DOUBLE ANTIBIOTIC PLUS PAIN RELIEF  MAXIMUM STRENGTH
neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-822
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
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [USP'U]  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-822-34	1 in 1 CARTON	05/01/2009	04/01/2019
1		14 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 NOT FINAL	part347	05/01/2009	04/01/2019

Labeler - Fred's Inc. (005866116)

Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 5/2019

Document Id: d61cb26d-67b3-4dcd-abc1-853687ebf2d8

34390-5

Set id: e7710289-5cad-4448-b7e6-5ca1084043f2

Version: 6

Effective Time: 20190529