Icequake Coldn Hot medicated patch

Manufacturer: Southern Sales & Service, Inc.
Effective date: 2023-11-29
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 00:03:02

Label at a glance#

ProductIcequake Coldn Hot medicated patch

Active ingredientMENTHOL

Label structure7 sections

Indications and uses

Temporarily relieves minor pain associated with: • arthritis • muscle strains • simple backache • bursitis • cramps • tendonitis • muscle sprains • bruises

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain associated with: • arthritis • muscle strains • simple backache • bursitis • cramps • tendonitis • muscle sprains • bruises

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

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

OTC - DO NOT USE SECTION

if you are allergic to any ingredients of this product

Stop use and ask a doctor if

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RL1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
420222	menthol 5 % Medicated Patch	PSN	4
420222	menthol 0.05 MG/MG Medicated Patch	SCD	4
420222	menthol 5 % Medicated Patch	SY	4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69822-014-04	Icequake Coldn Hot medicated patch	4 in 1 POUCH	CLOTH	4		4
69822-014-04	Icequake Coldn Hot medicated patch	9.5 g in 1 PATCH	CLOTH	9.5		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69822-014	ICEQUAKE COLDN HOT MEDICATED PATCH (MENTHOL) CLOTH [SOUTHERN SALES & SERVICE, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20231201_89202c52-9eb7-4e5a-a709-4a66ab0d3a72.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

Icequake Coldn Hot medicated patch
MENTHOL
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)

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69822-014	69822-014-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TARTARIC ACID	W4888I119H	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
CARBOXYMETHYLCELLULOSE	05JZI7B19X	IACT
DIHYDROXYALUMINUM AMINOACETATE	DO250MG0W6	IACT
GLYCERIN	PDC6A3C0OX	IACT
KAOLIN	24H4NWX5CO	IACT
POVIDONE	FZ989GH94E	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
MINERAL OIL	T5L8T28FGP	IACT
PETROLATUM	4T6H12BN9U	IACT
POLYACRYLIC ACID (250000 MW)	9G2MAD7J6W	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
SODIUM POLYACRYLATE (8000 MW)	285CYO341L	IACT
MENTHOL	L7T10EIP3A	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Icequake Coldn Hot medicated patch	MENTHOL	Southern Sales & Service, Inc.	89202c52-9eb7-4e5a-a709-4a66ab0d3a72	2023-11-29	Warnings	Exact identifier ndc (package): 69822-014-04 ndc (product): 69822-014 ndc11 (package): 69822001404 spl id: 0b57dc81-5724-2787-e063-6394a90a04b0 spl set id: 89202c52-9eb7-4e5a-a709-4a66ab0d3a72

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.