NDC | 69837-510-09, 69837-510-10 |
Set ID | cc3fdc61-8823-48a5-ab65-8366e2fbf04a |
Category | HUMAN OTC DRUG LABEL |
Packager | International Brand Management, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- Active Ingredient
- Purpose
- Uses
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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.
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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.
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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
- Inactive Ingredients
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SURE RESULT SR RELIEF
capsaicin creamProduct 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)