IceQuake Coldn Hot Medicated Patch

IceQuake Coldn Hot Medicated by

Drug Labeling and Warnings

IceQuake Coldn Hot Medicated by is a Otc medication manufactured, distributed, or labeled by Southern Sales & Service, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ICEQUAKE COLDN HOT MEDICATED- menthol patch 
Southern Sales & Service, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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IceQuake Coldn Hot Medicated Patch

Drug Facts

Active Ingredient

Menthol 5%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pain associated with:

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

Warnings

For external use only

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
  • 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

Directions

Adults and children over 12 years

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

Children under 12 years of age

Consult a physician

Other information

store at room temperature

Inactive Ingredients

aluminum glycinate, castor oil, concentrate glycerin, disodium edetate hydrate, gelatin, glycol salicylate, isopropyl myristate, mentha oil, polysorbate 80, polyvinyl alcohol, polyvinylpyrrolidone, purified water, sodium polyacrylate, tataric acid, titanium oxide

IceQuake Coldn Hot Medicated Patch 69822-010-04

Bottle label

ICEQUAKE COLDN HOT MEDICATED 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69822-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
CASTOR OIL (UNII: D5340Y2I9G)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCOL SALICYLATE (UNII: 3I1VBB7AXH)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69822-012-014 in 1 PACKAGE03/01/201908/31/2025
11 in 1 PACKET
19.5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/201908/31/2025
Labeler - Southern Sales & Service, Inc. (013114906)
Registrant - Southern Sales & Service, Inc. (013114906)

Revised: 7/2023
Document Id: 00383aa5-130c-f75f-e063-6294a90ab305
Set id: e08b7fb5-260f-42a4-97ad-2083b9f440a0
Version: 3
Effective Time: 20230711