FDA Label for Sure Result Sr Relief

View Indications, Usage & Precautions

Sure Result Sr Relief Product Label

The following document was submitted to the FDA by the labeler of this product International Brand Management, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


Otc - 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


Otc - Questions



FOR QUESTIONS OR COMMENTS:

[email protected]


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