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NDC 61787-0443-02 ZOSTRIX HP 0.75 mg/g Details

ZOSTRIX HP 0.75 mg/g

ZOSTRIX HP is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by MEDTECH PRODUCTS INC. The primary component is CAPSAICIN.

MedlinePlus Drug Summary

Topical capsaicin is used to relieve minor pain in muscles and joints caused by arthritis, backaches, muscle strains, bruises, cramps, and sprains. Capsaicin is a substance that is found in chili peppers. It works by affecting nerve cells in the skin that are associated with pain, which results in decreased activity of these nerve cells and a reduced sense of pain.

Related Packages: 61787-0443-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Capsaicin Topical

Product Information

NDC	61787-0443
Product ID	61787-443_6813564d-3c8c-4e02-9584-c9a78fcefe1e
Associated GPIs	90850025003735
GCN Sequence Number	058057
GCN Sequence Number Description	capsaicin CREAM (G) 0.1 % TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	23373
HICL Sequence Number	002577
HICL Sequence Number Description	CAPSAICIN
Brand/Generic	Generic
Proprietary Name	ZOSTRIX HP
Proprietary Name Suffix	n/a
Non-Proprietary Name	Capsaicin
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	0.75
Active Ingredient Units	mg/g
Substance Name	CAPSAICIN
Labeler Name	MEDTECH PRODUCTS INC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 61787-0443-02 (61787044302)

Pricing Information	N/A
NDC Package Code	61787-443-02
Billing NDC	61787044302
Package	1 TUBE in 1 CARTON (61787-443-02) / 56.6 g in 1 TUBE
Marketing Start Date	2006-01-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5a9e970c-7e67-469d-b9ad-010c031ed35b Details

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

Total Capsaicin 0.1%

Purpose

Topical Analgesic

Uses

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

• arthritis • simple backache • strains • sprains

Warnings

For external use only.

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

When using this product

• 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

•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

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

Directions

•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

Store at 15° - 30°C (59° - 86°F)

Inactive Ingredients

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?

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

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)

INGREDIENTS AND APPEARANCE

ZOSTRIX HP

capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61787-443
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.75 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PEG-100 STEARATE (UNII: YD01N1999R)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
PETROLATUM (UNII: 4T6H12BN9U)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:61787-443-02	1 in 1 CARTON	01/09/2006
1		56.6 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/09/2006

Labeler - MEDTECH PRODUCTS INC (114707784)

Name	Address	ID/FEI	Business Operations
Establishment
Denison Pharmaceuticals, LLC		001207208	manufacture(61787-443)

Revised: 3/2022

Document Id: 6813564d-3c8c-4e02-9584-c9a78fcefe1e

Set id: 5a9e970c-7e67-469d-b9ad-010c031ed35b

Version: 6

Effective Time: 20220301