katinko external analgesic oil

katinko external analgesic oil
SPL v2
SPL
SPL Set ID 5881fc35-3293-4f0b-801a-afcd6feb9496
Route
topical
Published
Effective Date 2023-05-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
camphor (synthetic) (50 mg) menthol (160 mg) salicylic acid (300 mg)
Inactive Ingredients
mineral oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-06-01

Purpose

External analgesic

Description

Camphor 5% Menthol 16% Methyl salicylate 30%


Medication Information

Warnings

For external use only

Purpose

External analgesic

Directions
  • Adults and children 3 years of age and older. Apply to affected area not more than 3 to 4 times daily
  • Children under 3 years of age: Consult a doctor.
Description

Camphor 5% Menthol 16% Methyl salicylate 30%

Use
  • For the temporary relief of minor aches and pains of muscles and joints.
Drug Facts

Active ingredients

Camphor 5% Menthol 16%

Methyl salicylate 30%

Inactive ingredients

Light Mineral Oil

When Using This product
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use otherwise than as directed
Package Labeling:52241 301 01

Package Labeling:52241 301 02

Stop Use and Ask A doctor If
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • excessive irritation of the skin develops
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away. to avoid accidental poisoning.


Structured Label Content

Warnings

For external use only

Purpose

External analgesic

Directions
  • Adults and children 3 years of age and older. Apply to affected area not more than 3 to 4 times daily
  • Children under 3 years of age: Consult a doctor.
Use
  • For the temporary relief of minor aches and pains of muscles and joints.
Drug Facts

Active ingredients

Camphor 5% Menthol 16%

Methyl salicylate 30%

Inactive ingredients

Light Mineral Oil

When Using This product (When using this product)
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use otherwise than as directed
Package Labeling:52241 301 01 (Package Labeling:52241-301-01)

Package Labeling:52241 301 02 (Package Labeling:52241-301-02)

Stop Use and Ask A doctor If (Stop use and ask a doctor if)
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • excessive irritation of the skin develops
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. to avoid accidental poisoning.


Advanced Ingredient Data


Raw Label Data

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