Label: DERMACINRX PENETRAL CREAM- capsaicin cream

  • 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 February 6, 2019

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

  • Active ingredient

    Capsicum Oleoresin 0.0625% (containing capsaicin 0.025%)

    Purpose

    Topical Analgesic

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  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, strains, and sprains.

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  • 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, sauna or vigorous exercise. Warm water, perspiration or open pores can intensify the impact of this product and cause a burning 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 eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually 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 product immediately and get medical attention if experiencing burning, pain, swelling, or blistering of the skin. Rare cases of severe burning or blistering have been reported.

    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 to fresh air. If breathing is difficult, get medical attention immediately.

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  • 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 first use, apply to small area to test for sensitivity or skin reaction.
    • Gently massage into the skin until fully absorbed.
    • Wash hands with soap and water thoroughly after each application to avoid spreading to the eyes or other sensitive mucous membranes.
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  • Other information

    WARNING: FLAMMABLE PRODUCT
    Store in a cool well ventilated area away from heat. Keep away from sparks or open flame.

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  • Inactive ingredients

    Acrylates Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Arnica Montana Flower Extract, Ethyl Alcohol, Ethyl Menthane Carboxamide, Ethylhexylglycerin, Euterpe Oleracea (Acai) Fruit Oil, Glycerin, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Lauryl Laurate, Linum Usitatissimum (Flax) Seed Oil, Mentha Piperita (Peppermint) Oil, Menthyl Lactate, Methyl Diisopropyl Propionamide, Phenoxyethanol, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinals (Rosemary) Oil, Triethanolamine.

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  • Questions or comments?

    Call toll-free 1-877-921-7873 or visit us at www.dermacinrx.com

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  • DermacinRx ® Penetral™ Cream (8 fl oz bottle label)
  • INGREDIENTS AND APPEARANCE
    DERMACINRX PENETRAL CREAM 
    capsaicin cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59088-310
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAPSICUM OLEORESIN (UNII: UW86K581WY) (CAPSICUM OLEORESIN - UNII:UW86K581WY) CAPSAICIN 0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    ALCOHOL (UNII: 3K9958V90M)  
    ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EUTERPE OLERACEA WHOLE (UNII: Y57H6218HP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE (UNII: 9CO8OUL4TH)  
    LAURYL LAURATE (UNII: GPW77G0937)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    FLAX SEED (UNII: 4110YT348C)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59088-310-16 237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/09/2015
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 06/09/2015
    Labeler - PureTek Corporation (785961046)
    Establishment
    Name Address ID/FEI Business Operations
    PureTek Corporation 785961046 manufacture(59088-310)
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