Sure Result SR Relief

Manufacturer
International Brand Management, LLC
Effective date
2017-06-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:51:43

Label at a glance#

ProductSure Result SR Relief
Active ingredientCAPSAICIN
Label structure10 sections

Indications and uses

Uses for the temporary relief of minor aches and painsof muscles and joints associated with a simple backache, athritis, strains and sprains

Dosage and administration

Directions Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock. Before using on children under 18 years of age consult a physician. Apply sparingly to affected area not more than 4 times daily. However, for the first use, apply to small area to test for sensitivity or skin reaction. Gently massage into skin until fully absorbed. Wash hands with soap and water thoroughly after each applicati...

Storage and handling

WARNING: FLAMMABLE PRODUCT Store in a cool well ventilated area away from heat. Keep away from sparks or open flame.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Capsaicin 0.025%

Purpose

OTC - PURPOSE SECTION

Purpose

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Uses

for the temporary relief of minor aches and painsof muscles and joints associated with a simple backache,

athritis, strains and sprains

Warnings

WARNINGS SECTION

Warnings

For external use only

  • This is not a face cream. Do not apply to the face.
  • Do not use if allergic to chili peppers or if past allergic reaction to capsaicin
  • Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin.
  • Do not bandage tightly
  • Do not apply within 1 hour before or after bath, shower, hot tub, saunaor vigrous exercise
  • Warm water, perspiration or open pores can intensify the impact of this product and bruning sensation.
  • Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burns.

When using this product  Do not get into eyesand avoid contact with mucous membranes. If contact

occurs or if pain, discomfort or skin redness occurs, continuously rinse with cool water and seek medical help.

Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear

up and occur again within a few days. Stop using and get immediate medical attention if experience burning,

pain, swelling or blistering of the skin. Rare cases of severe burning or blistering have been reported.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If pregnant, breast-feeding or any medical conditions exist, ask a health professional before use.

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

If inhaled, remove the fresh air. If breathing is difficult, get medical attention immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

  • Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock.
  • Before using on children under 18 years of age consult a physician.
  • Apply sparingly to affected area not more than 4 times daily. However, for the first use, apply to small area to test for sensitivity or skin reaction.
  • Gently massage into skin until fully absorbed.
  • Wash hands with soap and water thoroughly after each applicationto avoid spreading to the eyes or other sensitive mucous membranes.

STORAGE AND HANDLING SECTION

WARNING: FLAMMABLE PRODUCT

Store in a cool well ventilated area away from heat. Keep away from sparks or open flame.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice,

Aqua (Deionized Water), Arnica Montana Extract, Bosswellia Serrata Extract,

Cetyl Alcohol, Ethylhexylglycerin, Isopropyl Myristate, PEG-8,

Phenoxyethanol, Polysorbate-20, Triethanolamine

OTC - QUESTIONS SECTION

FOR QUESTIONS OR COMMENTS:

info@pindintl.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69837-510-102020-01-31C16284748780-19d75b9d0-07bd-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69837-510-09Sure Result SR Relief118 g in 1 TUBECREAM1181
69837-510-10Sure Result SR Relief1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69837-510SURE RESULT SR RELIEF (CAPSAICIN) CREAM [INTERNATIONAL BRAND MANAGEMENT, LLC]1Legacy NDC, 2 package rows20170624_cc3fdc61-8823-48a5-ab65-8366e2fbf04a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69837-510-10ML - Milliliter69837-5106f8730b3-9354-4357-a18c-13b40014022612017-08-11

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69837-51069837-510-09, 69837-510-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
843515b8-434a-4c37-a54c-da0dc912afa4cc3fdc61-8823-48a5-ab65-8366e2fbf04a2017-06-23WarningsExact identifier
spl id: 843515b8-434a-4c37-a54c-da0dc912afa4
spl set id: cc3fdc61-8823-48a5-ab65-8366e2fbf04a

Reported adverse events (FAERS/openFDA)#

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