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NDC 11822-0637-02 antibiotic plus pain relief 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g Details

antibiotic plus pain relief 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g

antibiotic plus pain relief is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Rite Aid Corporation. The primary component is NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE.

Product Information

NDC	11822-0637
Product ID	11822-0637_356bfcb1-8c4c-4464-889f-f2e4dd322109
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	antibiotic plus pain relief
Proprietary Name Suffix	maximum strength
Non-Proprietary Name	Neomycin, Polymyxin B, Pramoxine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	3.5; 10000; 10
Active Ingredient Units	mg/g; [USP'U]/g; mg/g
Substance Name	NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Labeler Name	Rite Aid Corporation
Pharmaceutical Class	Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333B
Listing Certified Through	2024-12-31

Package

Package Images

NDC 11822-0637-02 (11822063702)

Pricing Information	N/A
NDC Package Code	11822-0637-2
Billing NDC	11822063702
Package	1 TUBE in 1 CARTON (11822-0637-2) / 28 g in 1 TUBE
Marketing Start Date	2018-10-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b1b32f48-91e5-4c94-bbf5-091b8d177ef5 Details

Active ingredients (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 of Neosporin® + Pain Relief

MAXIMUM STRENGTH

first aid

antibiotic + pain relief cream

neomycin sulfate ● polymyxin B sulfate ● pramoxine HCl

first aid antibiotic/pain relieving cream

helps prevent infection and for temporary relief of pain due to minor cuts, scrapes and burns

NET WT 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

ANTIBIOTIC PLUS PAIN RELIEF MAXIMUM STRENGTH

neomycin, polymyxin b, pramoxine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-0637
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11822-0637-1	1 in 1 CARTON	07/14/2005
1		14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:11822-0637-2	1 in 1 CARTON	10/03/2018
2		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	07/14/2005

Labeler - Rite Aid Corporation (014578892)

Revised: 10/2018

Document Id: 356bfcb1-8c4c-4464-889f-f2e4dd322109

Set id: b1b32f48-91e5-4c94-bbf5-091b8d177ef5

Version: 4

Effective Time: 20181003