ICEQUAKE COLD HOT- menthol patch

ICEQUAKE Cold Hot by

Drug Labeling and Warnings

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

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

Southern Sales Services Inc
Pembroke Pines, FL 33332

INGREDIENTS AND APPEARANCE

ICEQUAKE COLD HOT 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69822-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69822-010-04	4 in 1 BOX	03/01/2019
1		9 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/01/2019

Labeler - Southern Sales & Service, Inc. (013114906)