Pain Relief Cream

Pain Relief Cream
SPL v2
SPL
SPL Set ID 6d87138f-5979-4e23-bd9e-ce96df1bd6f0
Route
TOPICAL
Published
Effective Date 2023-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2 g)
Inactive Ingredients
Arnica Montana Flower Angelica Sinensis Root Papaya Myrrh Heracleum Hemsleyanum Whole Homalomena Occulta Root Boswellia Sacra Whole Glycerin Medium-chain Triglycerides Laurocapram Squalane Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-09-06

Description

Menthol 2%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 2%

Use

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
Section 50565-1

Keep out of reach of children. If swallowed,get medical help or contact a Poison Contriol Center right away.

Section 50566-9

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.
  • Redness is present or irritation develops.
Section 50567-7

Use only as directed.Read and follow all directions and warmings on this label.

If pregnant or breast-feeding,ask a health professional before use.

Section 51945-4

Warnings

For external use only

Allergy alert:If prone to allergic reaction from aspirin or salicylates,consult a doctor before use.

Directions
  • For Use By Adults Only
  • Apply generously to affected area.
  • Massage into painful area until thoroughly absorbed into skin
  • Repeat as necessary.Repeat up 4 times a day.
Do Not Use
  • Do not bandage tightly or aooly local heat (such as heating pads) to the aera of use.
  • Avoid contact with eyes or mucous membranes.
  • Do not apply to wounds or damaged broken or irritated skin.
  • Do not use at the same time as other topical analgesics.
Active Ingredient

Menthol 2%

Arnica Montana Flower Extract,


Structured Label Content

Use

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed,get medical help or contact a Poison Contriol Center right away.

Section 50566-9 (50566-9)

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.
  • Redness is present or irritation develops.
Section 50567-7 (50567-7)

Use only as directed.Read and follow all directions and warmings on this label.

If pregnant or breast-feeding,ask a health professional before use.

Section 51945-4 (51945-4)

Purpose

Topical analgesic

Warnings

For external use only

Allergy alert:If prone to allergic reaction from aspirin or salicylates,consult a doctor before use.

Directions
  • For Use By Adults Only
  • Apply generously to affected area.
  • Massage into painful area until thoroughly absorbed into skin
  • Repeat as necessary.Repeat up 4 times a day.
Do Not Use (Do not use)
  • Do not bandage tightly or aooly local heat (such as heating pads) to the aera of use.
  • Avoid contact with eyes or mucous membranes.
  • Do not apply to wounds or damaged broken or irritated skin.
  • Do not use at the same time as other topical analgesics.
Active Ingredient

Menthol 2%

Arnica Montana Flower Extract, (ARNICA MONTANA FLOWER extract,)


Advanced Ingredient Data


Raw Label Data

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