Katinko Pain And Itch Relieving Ointment
FDA Label NDC 52241-100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Greenstone Pharmaceutical Inc. for the product Katinko Pain And Itch Relieving (NDC 52241-100). 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 otc - active ingredient, purpose, uses:, warnings, otc - when using, otc - stop use, keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active Ingredients:           

Camphor 11 percent                 

Menthol 7.6 percent                 

Methyl Salicylate 13.0 percent  

Purpose

Topical Analgesic

Topical Analgesic

Topical Analgesic

Uses:

For temporary relief of minor aches and pains of muscles and joints associated with:

Simple Backache       Arthritis      Rheumatism      Muscle Strain      Sprains      Bruises

For temporary relief of pain and itching associated with:

Insect Bites      Minor skin irritation

Warnings

Warnings

For External Use Only.

Otc - When Using

When using this product:

Use only as directed.

Do not apply to wounds or damaged skin.

Do not use on the eyes or on the mucous membranes.

Do not use with a heating pad or apply external heat.

Otc - Stop Use

Stop use and ask a doctor if:

Skin redness or excessive irritation of the skin occurs

Condition worsens

Symptoms persists for more than 7 days or clears up and occurs again within a few days

Do not bandage tightly

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a poison control

Dosage & Administration

Directions:

Adults and children 2 yrs and up              Apply to affected areas not more than 3 to 4 times daily

Children under 2 years                             Consult a doctor before use

Other Information

This product make provoke allergic reaction in some individuals. Test on small area before use.

Inactive Ingredients

Petroleum Jelly, Paraffin Wax

Manufactured By:

Greenstone

Pharmaceutical

H.K. Inc.

Anabu Industrial Estate,

Imus, Cavite, Philippines 4103

PRODUCT O F THE PHI L I P PI N E S

MEDICATED

For external use only

Package Label.Principal Display Panel

METHYL SALICYLATE

MENTHOL

CAMPHOR

KATINKO

OINTMENT

TOPICAL ANALGESIC OINTMENT

NET WT

1.1 FL. OZ (30 G)

0.36 OZ (10 G)

0.11 OZ (3 G)

DO NOT PURCHASE IF CARTON IS OPENED

FOR PAIN AND ITCH RELIEF

Katinko Pain And Itch Relieving Ointment

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