Theraplusplus
FDA Label NDC 55621-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zhejiang Jingwei Pharmaceutical Co., Ltd. for the product Theraplusplus (NDC 55621-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding inactive ingredient, otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Inactive Ingredient

Inactive Ingredients mineral oil, petrolatum

Otc - Active Ingredient

Active Ingredient (in each gram)

Bacitracin 400 units

Neomycin 3.5 mg

Polymyxcin B 5,000 units

Otc - Purpose

Purpose

First aid antibiotic

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

Uses first aid to help prevent infection in minor:

-cuts

-scrapes

-burns

Warnings

Warnings For external use only

Dosage & Administration

Directions

adults and children 2 years of age and older:

-clean the affected area

-apply a small amount of this product to affected area 1 to 3 times daily

-may be covered with a small bandage

Children under 2 years of age: ask a doctor before use


Otc - Stop Use

Stop use and ask a doctor if

-symptoms last for more than 7 days, the condition persists or gets worse

-symptoms clear up and then occur again within a few days

-a rahs or other allergic reaction occurs

Otc - Ask Doctor

Ask a doctor before use if you have

deep or puncture wounds

animal bites

serious burns

Package Label.Principal Display Panel

Copy Of Label (Zhejiang Antibioticlabel)

Copy Of Label (Zhejiang Antibioticlabel)

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