NU CALMAR- undecylenic acid cream 
Nu Calmar Pty Ltd

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.

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DRUG FACTS
Active Ingredient

Undecylenic Acid 20%

Purpose

Anti-fungal

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)

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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)

Revised: 11/2022
Document Id: eca759ee-4199-2762-e053-2a95a90aed5a
Set id: 0481e2c1-877b-4205-a6c0-493c6e8df7d1
Version: 6
Effective Time: 20221104
 
Nu Calmar Pty Ltd