Label: MELT PAIN AWAY- capsaicin cream

  • NDC Code(s): 72683-003-01, 72683-003-02
  • Packager: Proximity Capital Partners LLC dba Asutra
  • 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.

Drug Label Information

Updated April 15, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Capsaicin .025%

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    Temporarily relieves minor aches and pains of muscles and joints associated with:

    • arthritis
    • simple backache
    • strains
    • sprains
    • bruises

  • WARNINGS

    Use only as directed.

    For external use only.

    When using this product:

    • avoid contact with eyes
    • do not apply to wounds or damaged skin
    • do not bandage tightly

    Stop use and ask doctor if:

    • condition worsens
    • symptoms persist for more than 7 days, or clear up and reoccur again with a few days
    • redness is present
    • irritation develops.

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children. If accidentally ingested, get medical help or contact Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Adults and children over 18 years:

    • Apply to affected area. Massage into the painful area until thoroughly absorbed. Repeat as necessary but no more than 3 to 4

    times daily.

    • Wash hands with soap and water after applying.

    Children 18 years and younger:

    • Consult a doctor.

  • STORAGE AND HANDLING

    • Store in a cool, dry place.
    • Keep away from excessive heat or flame.
    • Tamper-evident for your protection. Use only if safety seal is intact
  • INACTIVE INGREDIENT

    Water, Magnesium Chloride, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Dimethyl Sulfone (MSM), Sodium Lactate, Glyceryl Stearate Citrate, Cetyl Palmitate, Glycerin, Glyceryl Stearate, Polyglyceryl-3 Diisostearate, Pentylene Glycol, Undecane, Xanthan Gum, Magnesium Sulfate, Tridecane, Potassium Chloride, Sodium Chloride, Calcium Chloride, Tocopheryl Acetate (Vitamin E), Hydroxyacetophenone, Panthenol, Allantoin, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Sodium Hydroxide, Cymbopogon Flexuosus (East-Indian Lemongrass) Oil* *Organic

  • QUESTIONS

    888-819-6472; Monday–Friday, 9am–5pm CT
    Report any serious side effects to number above.

  • PRINCIPAL DISPLAY PANEL

    Melt Pain Away

  • INGREDIENTS AND APPEARANCE
    MELT PAIN AWAY 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72683-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CYMBOPOGON FLEXUOSUS LEAF (UNII: 7LJ4Y1UJG7)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    UNDECANE (UNII: JV0QT00NUE)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TRIDECANE (UNII: A3LZF0L939)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALLANTOIN (UNII: 344S277G0Z)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72683-003-01200 g in 1 JAR; Type 0: Not a Combination Product04/15/2020
    2NDC:72683-003-021.9 g in 1 PACKET; Type 0: Not a Combination Product04/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/15/2020
    Labeler - Proximity Capital Partners LLC dba Asutra (081214985)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOLITEINT Kozmetikum gyarto es forgalmazo termelo es kereskedelmi Korlatolt Felelossegu Tarsasag401476254manufacture(72683-003)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!