ICEQUAKE COLD HOT- 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 Cold'n Hot

WARNINGS

For External Use Only.

ACTIVE INGREDIENT

Active Ingredient ...............................................................................................Purpose
Menthol 5%...............................................................................................Topical Analgesic

INACTIVE INGREDIENT

Aluminium glycinate,1,3-buthylene Glycol, Carboxymethylcellulose Sodium, Concentrated Glycerin, diethylene Glycolmonoethyl Ether, Disodium Edetate, Methyl Parahydroxybenzoate, Polyacrylic Acid Solution, Polysorbate 80, Propyl Parahydroxybenzoate, Purified Water, Sodium Polyacrylate, Tartaric Acid, Titanium Oxide

INDICATIONS & USAGE

Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis<br />■ muscle strains ■ muscle sprains ■ bruises ■ cramps

DOSAGE & ADMINISTRATION

Adults and children 12 years of age and over: 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.

PURPOSE

Topical Analgesic

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.

■ Don’t apply to wounds or damaged skin.

■ Do not use if you are alergic to any ingredients of this product.

Stop use and ask a doctor

■ If condition worsens

■ If symptoms persist for more than 7 days or clear up and occur again within a few days.

■ If redness is present

■ If irritation develops

KEEP OUT OF REACH OF CHILDREN

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

If pregnant or breastfeeding

ask a health professional before use.

Southern Sales Services Inc
Pembroke Pines, FL 33332

Patch Label Image
ICEQUAKE COLD HOT 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69822-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIETHYLENE GLYCOL (UNII: 61BR964293)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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:69822-010-044 in 1 BOX03/01/2019
19 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2019
Labeler - Southern Sales & Service, Inc. (013114906)

Revised: 3/2019
Document Id: e11da3ea-8265-4a09-8c9e-6637b0c56abb
Set id: 09774bab-f366-412f-a3fc-26f00f44928e
Version: 1
Effective Time: 20190311
 
Southern Sales & Service, Inc.