DCH Labs Antifungal Jock Powder

DCH LABS ANTIFUNGAL JOCK- miconazole nitrate 2% powder
Derma Care Research Labs, LLC

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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Miconazole Nitrate 2%

Antifungal

For the cure of athlete's foot and jock itch. Relieves itching and chafing associated with jock itch.

For external use only. Do not use on children under 2 years of age unless directed by a doctor or for diaper rash. When using thisproduct avoid contact with the eyes. Stop use and ask a doctor if irritation occurs or if there is no improvement within 2 weeks.

If swallowed, get medical help or contact a Poison Control Center right away.

Cleanse the affected area and dry thoroughly. Apply a thin layer of the product over the affected area twice daily or as directed by a doctor or healthcare professional. Supervise children in the use of this product.

Use daily for 2 weeks.

If the condition persists, consult a doctor.

This product is not effective on the scalp or nails.

Corn Starch, Fragrance, Potassium Sorbate, Rice Starch, Sodium Benzoate.

Label

DCH LABS ANTIFUNGAL JOCK
miconazole nitrate 2% powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72839-096
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SODIUM BENZOATE (UNII: OJ245FE5EU)
STARCH, CORN (UNII: O8232NY3SJ)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
STARCH, RICE (UNII: 4DGK8B7I3S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72839-096-02	71 g in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M005	01/14/2022

Labeler - Derma Care Research Labs, LLC (116817470)

Registrant - Derma Care Research Labs, LLC (116817470)

Name	Address	ID/FEI	Business Operations
Establishment
Derma Care Research Labs, LLC		116817470	manufacture(72839-096)