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NDC 00113-7679-21 Basic Care First Aid Antibiotic Plus Pain Relief 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g Details

Basic Care First Aid Antibiotic Plus Pain Relief 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g

Basic Care First Aid Antibiotic Plus Pain Relief is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by L. Perrigo Company. 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: 00113-7679-21
Last Updated: 11/30/2022
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: 00113-7679-21
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pramoxine

Product Information

NDC	00113-7679
Product ID	0113-7679_7fef39aa-cd70-4075-8f1d-6720b9e240e7
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	Basic Care First Aid Antibiotic Plus Pain Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bacitracin, Neomycin, 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	L. Perrigo Company
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 00113-7679-21 (00113767921)

Pricing Information	N/A
NDC Package Code	0113-7679-21
Billing NDC	00113767921
Package	3 TUBE in 1 CARTON (0113-7679-21) / 28 g in 1 TUBE (0113-7679-64)
Marketing Start Date	2019-06-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7fef39aa-cd70-4075-8f1d-6720b9e240e7 Details

Active ingredient (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 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 20-25°C (68-77°F)

Inactive ingredients

white petrolatum

Questions or comments?

1-800-719-9260

Principal Display Panel

3 PACK

Maximum Strength

Compare to Neosporin® active ingredients

first aid antibiotic plus pain relief

Bacitracin Zinc

Neomycin Sulfate

Polymyxin B Sulfate

Pramoxine HCl

First Aid Antibiotic

Pain Relieving

Ointment

24 Hour

Infection

Protection

Soothes painful cutes, scrapes and burns

NET WT. 3 OZ (85 g)

INGREDIENTS AND APPEARANCE

BASIC CARE FIRST AID ANTIBIOTIC PLUS PAIN RELIEF

bacitracin, neomycin, polymyxin b, pramoxine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0113-7679
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
PETROLATUM (UNII: 4T6H12BN9U)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0113-7679-21	3 in 1 CARTON	06/12/2019
1	NDC:0113-7679-64	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	06/12/2019

Labeler - L. Perrigo Company (006013346)

Revised: 6/2019

Document Id: 7fef39aa-cd70-4075-8f1d-6720b9e240e7

Set id: 7fef39aa-cd70-4075-8f1d-6720b9e240e7

Version: 1

Effective Time: 20190617