SURE RESULT SR RELIEF- capsaicin cream

Sure Result SR Relief by

Drug Labeling and Warnings

Sure Result SR Relief by is a Otc medication manufactured, distributed, or labeled by International Brand Management, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

KEEP OUT OF REACH OF CHILDREN

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.

STORAGE AND HANDLING

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

QUESTIONS

FOR QUESTIONS OR COMMENTS:

info@pindintl.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SURE RESULT SR RELIEF 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69837-510
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	.025 mg  in .001 g

Inactive Ingredients
Ingredient Name	Strength
(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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69837-510-10	1 in 1 CARTON	03/10/2016
1	NDC: 69837-510-09	118 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/10/2016

Labeler - International Brand Management, LLC (079794940)

Establishment
Name	Address	ID/FEI	Business Operations
International Brand Management, LLC		079794940	manufacture(69837-510)