Katinko Pain And Itch Relieving: Package Insert and Label Information

KATINKO PAIN AND ITCH RELIEVING- camphor (synthetic), menthol and methyl salicylate ointment
Greenstone Pharmaceutical Inc.

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.

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

For External Use Only.

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.

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

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

10g stickers
(click image for full-size original)
10g box
(click image for full-size original)

30g Package Label

30g Label
(click image for full-size original)

KATINKO PAIN AND ITCH RELIEVING
camphor (synthetic), menthol, methyl salicylate ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52241-100
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 11 g in 100 g
MENTHOL (MENTHOL) MENTHOL 7.6 g in 100 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 13 g in 100 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM
PARAFFIN
EUCALYPTUS OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52241-100-10 1 JAR in 1 CARTON contains a JAR
1 10 g in 1 JAR This package is contained within the CARTON (52241-100-10)
2 NDC:52241-100-03 1 JAR in 1 CARTON contains a JAR
2 3 g in 1 JAR This package is contained within the CARTON (52241-100-03)
3 NDC:52241-100-30 1 BOTTLE in 1 CARTON contains a BOTTLE
3 30 g in 1 BOTTLE This package is contained within the CARTON (52241-100-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 05/24/2010
Labeler — Greenstone Pharmaceutical Inc. (719794307)
Registrant — Greenstone Pharmaceutical Inc. (719794307)
Establishment
Name Address ID/FEI Operations
Greenstone Pharmaceutical Inc. 719794307 manufacture (52241-100)

Revised: 08/2021 Greenstone Pharmaceutical Inc.

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