menticam gel

menticam gel
SPL v3
SPL
SPL Set ID 081837a8-9669-be1f-e063-6394a90a9d20
Route
topical
Published
Effective Date 2023-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol, unspecified form (10 g) salicylic acid (30 g) camphor (synthetic) (4 g)
Inactive Ingredients
benzyl alcohol polysorbate 80 water carbomer homopolymer, unspecified type acrylates/c10-30 alkyl acrylate crosspolymer (60000 mpa.s) trolamine

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-10-26

Purpose

Camphor - Topical analgesic Menthol - Topical analgesic Methyl Salicylate - Topical analgesic

How Supplied

Menticam™ Gel is an anti-inflammatory anesthetic in a 3.5 oz/ 100 g tube. NDC 59088-203-07

Description

Drug Facts


Medication Information

Uses

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

  • simple bachache
  • arthritis
  • strains
  • bruises
  • sprains
Purpose

Camphor - Topical analgesic

Menthol - Topical analgesic

Methyl Salicylate - Topical analgesic

Directions
  • do not use otherwise than directed
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult a doctor
Other Information

Store at controlled room temperature 20°-25°C (68°-77°C).

Avoid excessive heat. Do not use if package is damaged. Keep out of reach of children.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aqua (Purified Water), Benzyl Alcohol, Carbomer, Polysorbate 80, Triethanolamine

How Supplied

Menticam™ Gel is an anti-inflammatory anesthetic in a 3.5 oz/ 100 g tube.

NDC 59088-203-07

Description

Drug Facts

Section 42229-5

Drug Facts

Warnings:

For external use only

Do Not Use
  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if you have redness over affected area

Menticam™ Gel

Active Ingredients

Camphor 4%

Menthol 10%

Methyl salicylate 30%

When Using This Product
  • use only as directed 
  • avoid contact with the eyes or mucous membranes 
  • do not bandage tightly
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • excessive skin irritation occurs
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

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

  • simple bachache
  • arthritis
  • strains
  • bruises
  • sprains
Purpose

Camphor - Topical analgesic

Menthol - Topical analgesic

Methyl Salicylate - Topical analgesic

Directions
  • do not use otherwise than directed
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult a doctor
Other Information (Other information)

Store at controlled room temperature 20°-25°C (68°-77°C).

Avoid excessive heat. Do not use if package is damaged. Keep out of reach of children.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aqua (Purified Water), Benzyl Alcohol, Carbomer, Polysorbate 80, Triethanolamine

How Supplied

Menticam™ Gel is an anti-inflammatory anesthetic in a 3.5 oz/ 100 g tube.

NDC 59088-203-07

Section 42229-5 (42229-5)

Drug Facts

Warnings:

For external use only

Do Not Use (Do not use)
  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if you have redness over affected area

Menticam™ Gel

Active Ingredients

Camphor 4%

Menthol 10%

Methyl salicylate 30%

When Using This Product (When using this product)
  • use only as directed 
  • avoid contact with the eyes or mucous membranes 
  • do not bandage tightly
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • excessive skin irritation occurs
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.


Advanced Ingredient Data


Raw Label Data

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