TheraCare Triple Antibiotic Pain relief Ointment

TheraCare Triple Antibiotic Pain Relief by

Drug Labeling and Warnings

TheraCare Triple Antibiotic Pain Relief by is a Otc medication manufactured, distributed, or labeled by Veridian Healthcare, ANICARE PHARMACEUTICALS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

THERACARE TRIPLE ANTIBIOTIC PAIN RELIEF- bacitracin,neomycin,polymxin, pramoxine ointment 
Veridian Healthcare

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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TheraCare Triple Antibiotic Pain relief Ointment

DRUG FACTS

Active Ingredient

Bacitracin zinc 500 Units

Neomycin sulfate (3.5mg)

Polymyxin B sulfate (10000 units)

Pramoxine HCI (10mg)

Purpose

First Aid Antibiotic

external analgesic

Uses

First Aid to help prevent infection and for temporary relief of pain in minor:

• Cuts
• Scrapes
• Burns

Warnings

For external use only.

Do not use

If you are allergic to any of the ingredients
In eyes
Over large areas of the body

Ask a Doctor before Use

Ask Doctor before use if you have:

• Deep or puncture wouns
• Animal bites
• Serious burns

When using this product

use only as directed

Stop Use and ask a Doctor if:

• You need to use longer than 1 week
• Condition persists or gets worse
• 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 or 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 doctor

Other Information

• Store at 20° to 25°C (68° to 77°F)
• do not use if tube seal under cap is broken

Inactive Ingredient:

Light mineral oil, hard paraffin, Petrolatum

Questions?

Call 866-326-1313

Packaging

THERACARE TRIPLE ANTIBIOTIC PAIN RELIEF 
bacitracin,neomycin,polymxin, pramoxine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-229
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN ZINC	500 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	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
PETROLATUM (UNII: 4T6H12BN9U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PARAFFIN (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-229-01	1 in 1 BOX	05/01/2023
1		28.3 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	05/01/2023

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
ANICARE PHARMACEUTICALS PRIVATE LIMITED		916837425	manufacture(71101-229)

Revised: 5/2023

Document Id: faf73908-3250-27f5-e053-6394a90aa06e

34390-5

Set id: faf73908-324f-27f5-e053-6394a90aa06e

Version: 1

Effective Time: 20230505