Soundbody Cold And Hot Pain Relief

Soundbody Cold And Hot Pain Relief
SPL v6
SPL
SPL Set ID 6bf338ea-f043-75dd-e053-2991aa0a408a
Route
TOPICAL
Published
Effective Date 2018-05-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (400 mg)
Inactive Ingredients
Polyacrylic Acid (8000 Mw) Polysorbate 80 Sodium Polyacrylate (8000 Mw) Glycerin Dihydroxyaluminum Aminoacetate Kaolin Methylparaben Propylene Glycol Propylparaben Water Tartaric Acid Titanium Dioxide Povidone Mineral Oil Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-05-11

Description

Menthol 5%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 5%

Uses

Temporarily relieves minor pain associated with:

  • arthritis
  • muscle strains
  • simple backache
  • bursitis
  • cramps
  • tendonitis
  • muscle sprains
  • bruises

Warnings

For external use only

Directions

Adults and children over 12 years:

  • Remove backing from patch by grasping both ends firmly and gently pulling until backing separates in middle
  • Carefully remove backing from patch
  • Apply one patch to affected area
  • Repeat as necessary, but no more than 4 times daily

Children under 12 years of age: Ask a doctor

Package Label

Cold and Hot Pain Relief Patch

Active Ingredient

Menthol 5%

Other Information

store at room temperature

Inactive Ingredients

dihydroxyaluminum aminoacetate, glycerol, kaolin, methylparaben, polyacrylic acid, propylene glycol, propylparaben, pvp, sodium polyacrylate, tartaric acid, titanium dioxide, tween 80, water

When Using This Product
  • use only as directed
  • do not bandage tightly
  • do not use a heating pad
  • avoid contact with eyes and mucous membrane
  • do not apply to wounds or damaged skin
  • do not use if you are allergic to any ingredients of this product
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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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


Structured Label Content

Uses

Temporarily relieves minor pain associated with:

  • arthritis
  • muscle strains
  • simple backache
  • bursitis
  • cramps
  • tendonitis
  • muscle sprains
  • bruises

Purpose

Topical analgesic

Warnings

For external use only

Directions

Adults and children over 12 years:

  • Remove backing from patch by grasping both ends firmly and gently pulling until backing separates in middle
  • Carefully remove backing from patch
  • Apply one patch to affected area
  • Repeat as necessary, but no more than 4 times daily

Children under 12 years of age: Ask a doctor

Package Label (package label)

Cold and Hot Pain Relief Patch

Active Ingredient

Menthol 5%

Other Information (Other information)

store at room temperature

Inactive Ingredients (Inactive ingredients)

dihydroxyaluminum aminoacetate, glycerol, kaolin, methylparaben, polyacrylic acid, propylene glycol, propylparaben, pvp, sodium polyacrylate, tartaric acid, titanium dioxide, tween 80, water

When Using This Product (When using this product)
  • use only as directed
  • do not bandage tightly
  • do not use a heating pad
  • avoid contact with eyes and mucous membrane
  • do not apply to wounds or damaged skin
  • do not use if you are allergic to any ingredients of this product
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

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

ask a health professional before use.

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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