Careone
FDA Label NDC 41520-076

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by American Sales Company for the product Careone (NDC 41520-076). 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 other, otc - purpose, uses, warnings, do not use, ask a doctor before use, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

DISTRIBUTED BY
AMERICAN SALES COMPANY
4201 WALDEN AVENUE
LANCASTER, NY 14086

Otc - Purpose

Active ingredients (each gram contains)Purpose
Neomycin sulfate 3.5 mgFirst aid antibiotic
Polymyxin B sulfate 10,000 unitsFirst aid antibiotic
Pramoxine hydrochloride 10 mgTopical analgesic

Uses

first aid to help prevent infection and for the temporary relief of pain or discomfort in

  • minor cuts
  • scrapes
  • burns

Warnings

For external use only

Do Not Use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week

Ask A Doctor Before Use

  • on deep or puncture wounds, animal bites, or serious burns

Stop Use And Ask A Doctor If

  • condition gets worse
  • condition persists for more than 7 days
  • condition clears up and occurs again within a few days
  • a rash or other allergic reaction develops

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.

Directions

Adults and children 2 years of age and older:

  • clean the affected area and dry thoroughly
  • 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: consult a doctor

Other Information

  • store at controlled room temperature
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredients

emulsifying wax, methylparaben, mineral oil, propylene glycol, purified water, white petrolatum

Principal Display Panel - 14.2 G Tube Carton

CAREONE™

MAXIMUM STRENGTH
ANTIBIOTIC CREAM + PAIN RELIEF
Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

FIRST AID ANTIBIOTIC / PAIN RELIEVING CREAM

NET WT 1/2 oz

(14.2 g)

Principal Display Panel (14.2 g Tube Carton)

Principal Display Panel (14.2 g Tube Carton)

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