Icequake Cold'n Hot Medicated Patch

Icequake Cold'n Hot Medicated Patch
SPL v4
SPL
SPL Set ID 89202c52-9eb7-4e5a-a709-4a66ab0d3a72
Route
TOPICAL
Published
Effective Date 2022-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (50 mg)
Inactive Ingredients
Tartaric Acid Titanium Dioxide Polysorbate 80 Carboxymethylcellulose Dihydroxyaluminum Aminoacetate Glycerin Kaolin Povidone Methylparaben Mineral Oil Petrolatum Polyacrylic Acid (250000 Mw) Propylene Glycol Water Propylparaben Sodium Polyacrylate (8000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-02

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:

store at room temperature Children under 12 years of age:

  • Carefully remove backing film from patch
  • Apply one patch to affected area
  • Use one patch at a time, 1 or 2 times a day
Drug Facts

Do Not Use
  • if you are allergic to any ingredients of this product
Active Ingredient

Menthol 5%

Other Information

store at room temperature

Package Labeling:

Inactive Ingredients

CARBOXYMETHYLCELLULOSE, DIHYDROXYALUMINUM AMINOACETATE, GLYCERIN, KAOLIN, METHYLPARABEN, MINERAL OIL, PETROLATUM, POLYACRYLIC ACID , PROPYLENE GLYCOL, POLYSORBATE 80, POVIDONE, PROPYLPARABEN, SODIUM POLYACRYLATE, TARTARIC ACID, TITANIUM DIOXIDE, 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 membranes
  • do not apply to wounds or damaged skin
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 conctact 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:

store at room temperature Children under 12 years of age:

  • Carefully remove backing film from patch
  • Apply one patch to affected area
  • Use one patch at a time, 1 or 2 times a day
Drug Facts

Do Not Use (do not use)
  • if you are allergic to any ingredients of this product
Active Ingredient (Active ingredient)

Menthol 5%

Other Information

store at room temperature

Package Labeling:

Inactive Ingredients

CARBOXYMETHYLCELLULOSE, DIHYDROXYALUMINUM AMINOACETATE, GLYCERIN, KAOLIN, METHYLPARABEN, MINERAL OIL, PETROLATUM, POLYACRYLIC ACID , PROPYLENE GLYCOL, POLYSORBATE 80, POVIDONE, PROPYLPARABEN, SODIUM POLYACRYLATE, TARTARIC ACID, TITANIUM DIOXIDE, 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 membranes
  • do not apply to wounds or damaged skin
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 conctact a Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

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