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NDC 69842-0669-64 Antibiotic, Pain and Scar 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g Details

Antibiotic, Pain and Scar 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g

Antibiotic, Pain and Scar is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. The primary component is BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Neomycin, polymyxin, and bacitracin combination is used to prevent minor skin injuries such as cuts, scrapes, and burns from becoming infected. Neomycin, polymyxin, and bacitracin are in a class of medications called antibiotics. Neomycin, polymyxin, and bacitracin combination works by stopping the growth of bacteria.

Related Packages: 69842-0669-64
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Neomycin, Polymyxin, and Bacitracin Topical

Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation or rashes; or dry, itchy skin. Pramoxine also may be used to treat soreness, burning, itching, and pain from hemorrhoids (''piles'') and other minor rectal irritations or itching. Pramoxine is in a class of medications called topical anesthetics. It works by stopping nerves from sending pain signals.

Related Packages: 69842-0669-64
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pramoxine

Product Information

NDC	69842-0669
Product ID	69842-669_40b0afde-51a3-4375-8e4d-1cea34494e2e
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, Pain and Scar
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bacitracin Zinc, Neomycin sulfate, Polymyxin B, Pramoxine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	500; 3.5; 10000; 10
Active Ingredient Units	[USP'U]/g; mg/g; [USP'U]/g; mg/g
Substance Name	BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Labeler Name	CVS Pharmacy
Pharmaceutical Class	Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], 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 69842-0669-64 (69842066964)

Pricing Information	N/A
NDC Package Code	69842-669-64
Billing NDC	69842066964
Package	1 TUBE in 1 CARTON (69842-669-64) / 28 g in 1 TUBE
Marketing Start Date	2017-02-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8bb6cb64-103f-454a-95ad-c2c56b9cf71a Details

Active ingredients (in each gram)

Bacitracin zinc 500 units

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

Other information

•: store at 20-25°C (68-77°F)

Inactive ingredients

cocoa butter, cottonseed oil, olive oil, petrolatum, sodium pyruvate, tocopheryl acetate

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredients in Neosporin® + Pain Itch Scar

MAXIMUM STRENGTH OINTMENT

Antibiotic Pain & Scar

BACITRACIN ZINC

NEOMYCIN SULFATE

POLYMYXIN B SULFATE

PRAMOXINE HCl

First aid antibiotic/pain relieving ointment

24-hour infection protection while minimizing appearance of scars from:

Cuts & scrapes

Itch

Burns

Package Contains One Tube

NET WT 0.5 OZ (14 g)

INGREDIENTS AND APPEARANCE

ANTIBIOTIC, PAIN AND SCAR

bacitracin zinc, neomycin sulfate, polymyxin b, pramoxine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-669
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [USP'U] 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 [USP'U] in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
COCOA BUTTER (UNII: 512OYT1CRR)
OLIVE OIL (UNII: 6UYK2W1W1E)
PETROLATUM (UNII: 4T6H12BN9U)
SODIUM PYRUVATE (UNII: POD38AIF08)
COTTONSEED OIL (UNII: H3E878020N)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color	YELLOW (Pale)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-669-58	1 in 1 CARTON	02/20/2017
1		14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:69842-669-64	1 in 1 CARTON	02/22/2017
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	02/20/2017

Labeler - CVS Pharmacy (062312574)

Revised: 3/2021

Document Id: 40b0afde-51a3-4375-8e4d-1cea34494e2e

Set id: 8bb6cb64-103f-454a-95ad-c2c56b9cf71a

Version: 3

Effective Time: 20210304