real time pain relief maxx plus topical analgesic lotion

real time pain relief maxx plus topical analgesic lotion
SPL v1
SPL
SPL Set ID fc509a55-594d-4d44-87db-33286e937581
Route
topical
Published
Effective Date 2024-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (19 mg)
Inactive Ingredients
aloe vera leaf water arnica montana flower calendula officinalis flower hemp caprylyl glycol capsaicin chamomile coriander oil emu oil glucosamine sulfate glycerin witch hazel st. john's wort c13-14 isoparaffin laureth-7 peppermint oil dimethyl sulfone phenoxyethanol salix alba (willow) bark extract sorbitol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-10-23

Purpose

Topical Analgesic

Description

Menthol 1.9%


Medication Information

Purpose

Topical Analgesic

Description

Menthol 1.9%

Questions?

877-787-7180

Uses:

Temporarily relieves minor pain associated with: Arthritis

  • Simple Backache 
  • Muscle Strains
  • Sprains
  • Bruises
  • Cramps
Warnings:

For external use only

Drug Facts

Directions:

Adults and Children over 2 years: Apply to affected area. Massage into painful area until thoroughly absorbed into skin. Repeat as necessary, but no more than 4 times daily. Children 2 years or younger: ask a doctor.

Active Ingredient

Menthol 1.9%

Other Ingredients:

*Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Calendula Officinalis Extract, Cannabis Sativa (Hemp)Seed Oil, Caprylyl Glycol, Capsaicin, Centaurea Cyanus (Cornflower) Extract, Chamomilla Matricaria (Chamomile) Extract, Chondroitin Sulfate, Coriandrum Sativum (Coriander) Fruit Oil, Emu Oil, Glucosamine Sulfate, Glycerin, Hamamelis Virginiana (Witch Hazel), Hypericum Perforatum (St. John's Wort) Extract, C13-14 Isoparaffin, Laureth-7, Mentha Piperita (Peppermint) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Salix Alba (Willow) Bark Extract, SD-Alcohol 40B, Sorbitol, Tilia Cordata (Linden) Bark Extract. *Denotes certified organic ingredient.

Package Labelling: 88ml

Package Labelling: 120ml

Package Labelling: 210ml

Package Labelling: 354ml

Package Labelling: 473ml

When Using This Product:

Use only as directed

  • Avoid contact with eyes or mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not bandage tightly
Package Labelling: 147.8ml

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
  • Irritation develops
Keep Out of Reach of Children.

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


Structured Label Content

Purpose

Topical Analgesic

Questions?

877-787-7180

Uses:

Temporarily relieves minor pain associated with: Arthritis

  • Simple Backache 
  • Muscle Strains
  • Sprains
  • Bruises
  • Cramps
Warnings:

For external use only

Drug Facts

Directions:

Adults and Children over 2 years: Apply to affected area. Massage into painful area until thoroughly absorbed into skin. Repeat as necessary, but no more than 4 times daily. Children 2 years or younger: ask a doctor.

Active Ingredient

Menthol 1.9%

Other Ingredients:

*Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Calendula Officinalis Extract, Cannabis Sativa (Hemp)Seed Oil, Caprylyl Glycol, Capsaicin, Centaurea Cyanus (Cornflower) Extract, Chamomilla Matricaria (Chamomile) Extract, Chondroitin Sulfate, Coriandrum Sativum (Coriander) Fruit Oil, Emu Oil, Glucosamine Sulfate, Glycerin, Hamamelis Virginiana (Witch Hazel), Hypericum Perforatum (St. John's Wort) Extract, C13-14 Isoparaffin, Laureth-7, Mentha Piperita (Peppermint) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Salix Alba (Willow) Bark Extract, SD-Alcohol 40B, Sorbitol, Tilia Cordata (Linden) Bark Extract. *Denotes certified organic ingredient.

Package Labelling: 88ml

Package Labelling: 120ml

Package Labelling: 210ml

Package Labelling: 354ml

Package Labelling: 473ml

When Using This Product: (When using this product:)

Use only as directed

  • Avoid contact with eyes or mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not bandage tightly
Package Labelling: 147.8ml

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 
  • Redness is present
  • Irritation 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.


Advanced Ingredient Data


Raw Label Data

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