ICEQUAKE COLDN HOT MEDICATED PATCH- menthol cloth

Icequake Coldn Hot medicated patch by

Drug Labeling and Warnings

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

Drug Details [pdf]

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 sprains  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 conctact a Poison Control Center right away

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

Other Information

store at room temperature

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

Package Labeling:

INGREDIENTS AND APPEARANCE

ICEQUAKE COLDN HOT MEDICATED PATCH 
menthol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69822-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
POVIDONE (UNII: FZ989GH94E)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69822-014-04	4 in 1 POUCH	11/02/2022
1		9.5 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 Drug	M017	11/02/2022

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