ZOSTRIX HP

Manufacturer: MEDTECH PRODUCTS INC | Denison Pharmaceuticals, LLC
Effective date: 2022-03-01
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: legacy-cache
Hydrated at: 2026-08-01 22:07:39

Label at a glance#

ProductZOSTRIX HP

Active ingredientCAPSAICIN

Label structure10 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with • arthritis • simple backache • strains • sprains

Dosage and administration

•for persons under 18 years of age, ask a doctor before using. •apply a thin film of cream to the affected area and gently rub in until fully absorbed. •for optimum relief, apply 3 to 4 times daily. •best results typically occur after 2 to 4 weeks of continuous use. • unless treating hands, wash hands thoroughly with soap and water immediately after use. •see package insert for more information.

Contacts and useful links#

PhoneLabel contact1-800-579-8327

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

ZOSTRIX HP- capsaicin cream
Medtech Products Inc., a Prestige Consumer Healthcare company

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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Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Total Capsaicin 0.1%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with

• arthritis • simple backache • strains • sprains

Warnings

WARNINGS SECTION

For external use only.

Do not apply to wounds or to damaged or irritated skin.

When using this product

OTC - WHEN USING SECTION

• you may experience a burning sensation which is normal and related to the way the product works. With regular use, this sensation generally diminishes.

• avoid contact with eyes. Do not get it on mucous membranes, into eyes, or on contract lenses. If this occurs, rinse the affected area thoroughly with water.

• do not apply immediately before or after activities such as bathing, swimming, sun bathing, or strenuous exercise.

• do not apply heat to the treated areas immediately before or after use.

• do not tightly wrap or bandage the treated area.

• avoid inhaling airborne material from dried residue. This can result in coughing, sneezing, tearing, throat or respiratory irritation.

Stop use and ask a doctor if

OTC - STOP USE SECTION

•condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

•blistering occurs.

•difficulty breathing or swallowing occurs.

•severe burning persists.

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

•for persons under 18 years of age, ask a doctor before using.

•apply a thin film of cream to the affected area and gently rub in until fully absorbed.

•for optimum relief, apply 3 to 4 times daily.

•best results typically occur after 2 to 4 weeks of continuous use.

•unless treating hands, wash hands thoroughly with soap and water immediately after use.

•see package insert for more information.

Other information

OTHER SAFETY INFORMATION

Store at 15° - 30°C (59° - 86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, cetyl alcohol, citric acid*, glyceryl stearate, isopropyl myristate, PEG-100 stearate, purified water, sorbitol solution & white petrolatum.

*May contain this ingredient to adjust pH.

Questions or Comments?

OTC - QUESTIONS SECTION

Call: 1-800-579-8327

Serious side effects associated with the use of this product may be reported to this number.

Zostrix.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

ZOSTRIX®

NATURAL PAIN RELIEF

Capsaicin 0.1% Topical Analgesic

BLOCKS YOUR BODY’S PAIN MESSENGER

ODOR FREE CREAM

WARMTH FROM CHILI PEPPERS

NET WT 2.0 OZ. (57 g)

PRINCIPAL DISPLAY PANEL MAXIMUM STRENGTH ZOSTRIX® NATURAL PAIN RELIEF Capsaicin 0.1% Topical Analgesic BLOCKS YOUR BODY’S PAIN MESSENGER ODOR FREE CREAM WARMTH FROM CHILI PEPPER...

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61787-443-02	GM - Gram	61787-443	26db8380-c68d-4377-8c2f-58838c10fb87	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CAPSAICIN	ACTIVE INGREDIENT	S07O44R1ZM	3
CAPSAICIN	ACTIVE MOIETY	S07O44R1ZM	3
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	3
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	3
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	3
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	3
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	3
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

ZOSTRIX HP
Capsaicin
BENZYL ALCOHOL
CETYL ALCOHOL
GLYCERYL MONOSTEARATE
ISOPROPYL MYRISTATE
PEG-100 STEARATE
WATER
SORBITOL
PETROLATUM
ANHYDROUS CITRIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61787-443	61787-443-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CAPSAICIN	S07O44R1ZM	ACTIB
BENZYL ALCOHOL	LKG8494WBH	IACT
CETYL ALCOHOL	936JST6JCN	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
PEG-100 STEARATE	YD01N1999R	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
PETROLATUM	4T6H12BN9U	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT

Source Document#

Source XML · Source PDF

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 3 · 174 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / AURICULAR (OTIC)	1 %w/v		Exact identifier — unii candidate 20 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRAVENOUS		1276 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, EMULSION / SUBCUTANEOUS		225 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / OPHTHALMIC	88.4 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / VAGINAL	0.75 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL, METERED / TRANSDERMAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / INTRAMUSCULAR		54 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / BUCCAL		5110 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / ORAL		360 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CONCENTRATE / ORAL	600 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / INTRA-ARTICULAR		23 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL / TOPICAL	1.16 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PEG-100 STEARATE	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / TOPICAL		552 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / INTRAVENOUS		242 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / INTRAVENOUS		400 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, EXTENDED RELEASE / ORAL		428 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / VAGINAL		140 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	OINTMENT / TOPICAL	2.2 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, EXTENDED RELEASE / ORAL		529 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	LOTION / TOPICAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / SUBCONJUNCTIVAL		252 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / TOPICAL	2 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	FILM / TRANSDERMAL	58.08 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / RECTAL		17 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SPRAY, METERED / NASAL	5 mg/1ml		Exact identifier — unii candidate 50 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE / DENTAL	14.6 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	LIQUID / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
PEG-100 STEARATE	PEG-100 MONOSTEARATE	YD01N1999R	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	EMULSION / TOPICAL	7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CREAM / VAGINAL		200 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	144 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER / ORAL		36000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, COATED / ORAL	0.25 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	GEL / TOPICAL		185 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL / TRANSDERMAL		85 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, EMULSION / INTRAMUSCULAR		225 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL / TOPICAL		29 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	OIL / TOPICAL		213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL, SPRAY / TOPICAL	6.89 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	8.4 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SPRAY / TOPICAL		3665 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	FILM, EXTENDED RELEASE / TRANSDERMAL	20.4 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / SUBCUTANEOUS	0.95 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SPRAY / NASAL		49 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	GEL / RECTAL		124 mg	Exact identifier — unii candidate 50 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
1740d7fa-c4f4-44e7-9959-7f6f68fd3552			5a9e970c-7e67-469d-b9ad-010c031ed35b	2025-01-17	Warnings	Exact identifier spl set id: 5a9e970c-7e67-469d-b9ad-010c031ed35b

Reported adverse events (FAERS/openFDA)#

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