Label: NU CALMAR- undecylenic acid cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 4, 2022

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

View All Sections
  • DRUG FACTS Active Ingredient

    Undecylenic Acid 20%

  • Purpose

    Anti-fungal

  • KEEP OUT OF REACH OF CHILDREN

  • Uses:

    Cures most Athlete's Foot, Jock Itch or Ringworm. For effective relief of itching, scaling, burning, redness, irritation, chafing associated with jock itch and itchy scaly skin between the toes.

  • Warning:

    For external use only. Do not use on children under 2 years of age unless directed by a doctor. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor.  

  • Directions:

    Wash the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a doctor. Supervise children in the use of this product. For athlete's foot. Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

  • Inactive ingredients:

    Shea butter, Coconut Oil, Lemon Oil, Jojoba wax, Tocopherol, Grape Seed Oil, Zinc Oxide, Glycerin (Vegetable)

  • Principal display panel

    image description

    image description

    image description

    image description

    image description

    image description

  • INGREDIENTS AND APPEARANCE
    NU CALMAR 
    undecylenic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73464-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    LEMON OIL (UNII: I9GRO824LL)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73464-001-01150 mL in 1 JAR; Type 0: Not a Combination Product01/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/29/2020
    Labeler - Nu Calmar Pty Ltd (745013724)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renu Laboratories, Inc.945739449manufacture(73464-001)
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!