NU CALMAR- undecylenic acid cream

NU CALMAR by

Drug Labeling and Warnings

NU CALMAR by is a Otc medication manufactured, distributed, or labeled by Nu Calmar Pty Ltd, Renu Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTSActive 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.

Principal display panel

INGREDIENTS AND APPEARANCE

NU CALMAR 
undecylenic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73464-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73464-001-01	150 mL in 1 JAR; Type 0: Not a Combination Product	01/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/29/2020

Labeler - Nu Calmar Pty Ltd (745013724)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, Inc.		945739449	manufacture(73464-001)