SURE RELIEF SR RELIEF - capsaicin cream 
International Brand Management, LLC

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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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

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

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

copy of label

SURE RELIEF SR RELIEF 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69837-210
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN.025 mg  in .001 g
Inactive Ingredients
Ingredient NameStrength
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA (UNII: O80TY208ZW)  
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POLYETHYLENE GLYCOL 800 (UNII: UH6KR4953D)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
TRIETHANOLAMINE GLUTAMATE (UNII: M71CZB7HUY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69837-210-101 in 1 CARTON
1NDC:69837-210-09118 g in 1 TUBE; Type 0: Not a Combination Product
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/FEIBusiness Operations
International Brand Management, LLC079794940manufacture(69837-210)

Revised: 3/2016
Document Id: 6a8ca084-49e3-4518-bf2c-4480fb6c2fe2
Set id: db8dc635-dba7-4846-a7d1-41b6428ec21e
Version: 1
Effective Time: 20160310
 
International Brand Management, LLC