k19 spray relief

k19 spray relief
SPL v3
SPL
SPL Set ID e2e1ca96-1ae8-4c99-b8de-ce26754292f9
Route
topical
Published
Effective Date 2023-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (12.5 mg)
Inactive Ingredients
water camphor (synthetic) glycerin glyceryl laurate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-07-10

Description

Menthol 1.25%


Medication Information

Description

Menthol 1.25%

Section 55105-1

Topical Analgesic

Warnings:
  • For external use only.
  • Avoid contact with eyes and mucous membranes.
  • If symptoms persist for more than 7 days, discontinue use and consult physician.
Drug Facts:

Directions:
  • Adults and children 2 years of age or older: Apply to affected area not more than 3 to 4 times daily.
  • Chidlren under 2 years of age: consult a physician.
Indications:

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and stains.

Package Labeling:

Active Ingredient:

Menthol 1.25%

Other Ingredients:

Aqua (Deionized Water), Camphor, Glycerin, Glyceryl Laurate, SD-Alcohol 40B.

Additional Information:

Store at room temperature.

If Pregnant Or Breast Feeding,

contact physician prior to use.

Keep Out of Reach of Children.
  • If swallowed, consult physician.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.

Structured Label Content

Section 55105-1 (55105-1)

Topical Analgesic

Warnings:
  • For external use only.
  • Avoid contact with eyes and mucous membranes.
  • If symptoms persist for more than 7 days, discontinue use and consult physician.
Drug Facts: (DRUG FACTS:)

Directions:
  • Adults and children 2 years of age or older: Apply to affected area not more than 3 to 4 times daily.
  • Chidlren under 2 years of age: consult a physician.
Indications:

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and stains.

Package Labeling:

Active Ingredient:

Menthol 1.25%

Other Ingredients:

Aqua (Deionized Water), Camphor, Glycerin, Glyceryl Laurate, SD-Alcohol 40B.

Additional Information:

Store at room temperature.

If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)

contact physician prior to use.

Keep Out of Reach of Children. (Keep Out of reach of children.)
  • If swallowed, consult physician.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.

Advanced Ingredient Data


Raw Label Data

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