Label: CHILL PAIN AWAY- capsaicin cream

  • NDC Code(s): 72683-004-01, 72683-004-02
  • 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 July 21, 2020

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

  • Actve Ingredients

    Capsaicin...0.025%

  • Purpose

    Topical Analgesic

  • Uses

    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. Keep away from excessive heat or flame

  • WHEN USING

    when using this product

    • avoid eye contact
    • do not apply to wounds or damaged skin
    • do no bandage tightly
  • STOP USE

    Stop use and ask doctor if:

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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask ahealth professional before use

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    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 doctor

  • Other Information

    • Store in a cool, dry place.
    • Tamper-evident for your protection. Use only if safety seal is intact.

  • Inactive Ingredients

    Water (Aqua), Magnesium Chloride, Dimethyl Sulfone (MSM), Prunus Amygdalus Dulcis (Sweet Almond
    Oil), Butyrospermum Parkii (Shea Butter), Sodium Lactate, Glyceryl Stearate, Undecane, Polygyceryl-6 Palmitate/Succinate, Pentene Glycol, Xylitylglucoside, Glyceryl Stearate Citrate, Glyceryl Stearate SE, Cetyl Palmitate, Cannabidiol Isolate, Anhydroxylitol, Xylitol, Cetearyl Alcohol, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Tridecane, Sodium Chloride, Potassium Chloride, Magnesium Sulfate, Calcium Chloride, Ascorbyl Palmitate, Hydroxyacetophenone, Disodium EDTA

  • PRINCIPAL DISPLAY PANEL

    PDP

  • INGREDIENTS AND APPEARANCE
    CHILL PAIN AWAY 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72683-004
    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
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    UNDECANE (UNII: JV0QT00NUE)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIDECANE (UNII: A3LZF0L939)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    POLYGLYCERYL-2 PALMITATE (UNII: V2A5PDC572)  
    XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    ANHYDROXYLITOL (UNII: 8XWR7NN42F)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72683-004-01100 g in 1 BOTTLE; Type 0: Not a Combination Product07/21/2020
    2NDC:72683-004-021.9 g in 1 PACKET; Type 0: Not a Combination Product07/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/21/2020
    Labeler - Proximity Capital Partners LLC dba Asutra (081214985)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOLITEINT Kozmetikum gyarto es forgalmazo termelo es kereskedelmi Korlatolt Felelossegu Tarsasag401476254manufacture(72683-004)