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Sure Relief SR Relief

Medically reviewed on March 12, 2018

Dosage form: cream
Ingredients: CAPSAICIN .025mg in .001g
Labeler: International Brand Management, LLC
NDC Code: 69837-210

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.

Active Ingredient

Active Ingredient

Capsaicin 0.025%

Purpose

Purpose

Topical Analgesic

Uses

Uses

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

athritis, strains and sprains

Warnings

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.

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

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.

WARNING: FLAMMABLE PRODUCT

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

Inactive Ingredients

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

FOR QUESTIONS OR COMMENTS:

info@pindintl.com

SURE RELIEF SR RELIEF 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69837-210
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (CAPSAICIN) CAPSAICIN.025 mg  in .001 g
Inactive Ingredients
Ingredient NameStrength
(C10-C30)ALKYL METHACRYLATE ESTER 
ALOE VERA LEAF 
WATER 
ARNICA MONTANA 
BOSWELLIA SERRATA RESIN OIL 
CETYL ALCOHOL 
ETHYLHEXYLGLYCERIN 
ISOPROPYL MYRISTATE 
POLYETHYLENE GLYCOL 800 
PHENOXYETHANOL 
POLYSORBATE 20 
TRIETHANOLAMINE GLUTAMATE 
Packaging
#Item CodePackage Description
1NDC:69837-210-101 TUBE in 1 CARTON
1NDC:69837-210-09118 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/10/2016
Labeler - International Brand Management, LLC (079794940)
Establishment
NameAddressID/FEIOperations
International Brand Management, LLC079794940manufacture(69837-210)

 
International Brand Management, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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