Label: GUARDANIA PAIN- capsaicin cream
- NDC Code(s): 71659-842-01
- Packager: LHP Pharma, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated August 10, 2017
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- Drug Facts:
- Active Ingredient:
For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.Close
•For external use only.
•Avoid contact with eyes.
•If symptoms persist for more than seven days, discontinue use and consult physician.
Keep out of reach of children.
•If swallowed, consult physician.
•Do not apply to wounds or damaged skin.
•Do not bandage tightly.
•Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.Close
•Children under two-years of age: consult a physician.
- Additional Information:
Store at room temperature.Close
- Other Ingredients:
Acrylates C10/30 Alkyl Acrylate Crosspolymer. Aloe Barbadensis Leaf (Aloe Vera Gel), Aqua (Deionized Water), Arnica Montana (Arnica) Extract, Boswellia Serrata Extract, Cetyl Alcohol, Ethylhexylglycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbate-20, TriethanolamineClose
- Package Labeling:
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71659-842 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.25 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) ARNICA MONTANA (UNII: O80TY208ZW) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) CETYL ALCOHOL (UNII: 936JST6JCN) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71659-842-01 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/10/2017 Labeler - LHP Pharma, Inc (080702471)