Assured Extra Strength Cold n hot

Manufacturer: Greenbrier International, Inc.
Effective date: 2013-06-30
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:35:57

Label at a glance#

ProductAssured Extra Strength Cold n hot

Active ingredientMENTHOL

Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

Menthol 5%.....................................................Topical Analgesic

OTC - PURPOSE SECTION

Uses Temporarily relieves minor pain associated with:

arthritis
simple backache
bursitis
tendonitis
muscle strains
muscle sprains
bruises
cramps

WARNINGS SECTION

Warnings

For external use only
If pregnant or breast-feeding, ask a health professional before use

OTC - WHEN USING SECTION

When using this product

use only as directed
do not bandage tightly or use with a heating pad
avoid contact with eyes and mucous membranes
do not apply to wounds or damaged skin

OTC - STOP USE SECTION

Stop use and ask a doctor if

condition worsens
symptoms persist more than 7 days or clear up and occur again within a few days
redness is present
skin irritation develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Directions

Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
Children under 12 years of age: do not use, consult a doctor
For easy application: partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin for secure adhesion.

INACTIVE INGREDIENT SECTION

Inactive ingredients aloe vera, aluminum hydroxide, disodium EDTA, gelatin, kaolin, methacrylic acid copolymer, methylparaben, polysorbate 80, sorbitan monooleate, sorbitol solution, tartaric acid, titanium dioxide, tocopheryl acetate (vitamin E), water

DOSAGE & ADMINISTRATION SECTION

Distributed by:

Greenbrier International, Inc.

500 Volvo Parkway

Chesapeake, VA 23320

Made in Korea

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1010823	menthol 7.5 % Medicated Patch	PSN	3
1010823	menthol 0.075 MG/MG Medicated Patch	SCD	3
1010823	menthol 7.5 % Medicated Patch	SY	3

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
33992-8463-2	2020-01-31	C162847	48780-1	9d75b9d0-c238-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
33992-8463-2	Assured Extra Strength Cold n hot	2 in 1 POUCH	PATCH	2		3
33992-8463-2	Assured Extra Strength Cold n hot	1 in 1 CARTON	PATCH	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33992-8463	ASSURED EXTRA STRENGTH COLD N HOT (MENTHOL) PATCH [GREENBRIER INTERNATIONAL, INC.]	3	Legacy NDC, 2 package rows	20130708_4b2a58d4-e298-45f3-9c09-ca8dccf57e04.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	3
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	3
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	3
ALUMINUM HYDROXIDE	INACTIVE INGREDIENT	5QB0T2IUN0	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	3
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	3
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	3
SORBITAN MONOOLEATE	INACTIVE INGREDIENT	06XEA2VD56	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	3
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Assured Extra Strength Cold n hot
Menthol
ALOE VERA LEAF
ALUMINUM HYDROXIDE
EDETATE DISODIUM
GELATIN
KAOLIN
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
METHYLPARABEN
POLYSORBATE 80
SORBITAN MONOOLEATE
SORBITOL
TARTARIC ACID
TITANIUM DIOXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
33992-8463	33992-8463-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MENTHOL	L7T10EIP3A	ACTIB
ALOE VERA LEAF	ZY81Z83H0X	IACT
ALUMINUM HYDROXIDE	5QB0T2IUN0	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
GELATIN	2G86QN327L	IACT
KAOLIN	24H4NWX5CO	IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	74G4R6TH13	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
SORBITAN MONOOLEATE	06XEA2VD56	IACT
SORBITOL	506T60A25R	IACT
TARTARIC ACID	W4888I119H	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 427 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CAPSULE / ORAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / OPHTHALMIC		8 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	3.6 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IONTOPHORESIS	0.1 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRADERMAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAVENOUS		7 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / PARENTERAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SYSTEM / TOPICAL		420 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	SUPPOSITORY / RECTAL		390 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		900 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY, METERED / NASAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	SYRUP / ORAL	10 mg/1ml		Exact identifier — unii candidate 13 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE / ORAL	418.37 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	PASTE / ORAL		28 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	74G4R6TH13	TABLET, DELAYED RELEASE / ORAL		172 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / SUBCUTANEOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, SOLUTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	CAPSULE, COATED PELLETS / ORAL		234 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAMUSCULAR	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / TOPICAL		126 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
TARTARIC ACID	TARTARIC ACID	W4888I119H	INJECTION / INTRAVENOUS	20 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SPRAY / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / NASAL	2 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CREAM / TOPICAL		80 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / RESPIRATORY (INHALATION)		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
TARTARIC ACID	TARTARIC ACID	W4888I119H	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	20 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	74G4R6TH13	CAPSULE, EXTENDED RELEASE / ORAL		225 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		2 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYRUP / ORAL		81 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	GRANULE, FOR SUSPENSION / ORAL		240 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	GEL / TOPICAL		12 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	ELIXIR / ORAL	1.3 mg/5ml		Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	CAPSULE, DELAYED RELEASE PELLETS / ORAL		234 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, SUSPENSION / INTRAMUSCULAR	1.3 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, EFFERVESCENT / ORAL		32 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE	1 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / VAGINAL		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, EXTENDED RELEASE / ORAL		1229 mg	Exact identifier — unii candidate 44 equally ranked IID candidates

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
dbce6c7d-a94c-48b4-9eb3-776c98f5b7e0			4b2a58d4-e298-45f3-9c09-ca8dccf57e04	2013-06-30	Warnings	Exact identifier spl id: dbce6c7d-a94c-48b4-9eb3-776c98f5b7e0 spl set id: 4b2a58d4-e298-45f3-9c09-ca8dccf57e04

Reported adverse events (FAERS/openFDA)#

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