DERMACHANGE JOCK- miconazole nitrate powder

Dermachange Jock by

Drug Labeling and Warnings

Dermachange Jock by is a Otc medication manufactured, distributed, or labeled by Private label Beauty and Wellness, Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Miconazole Nitrate 2%

PURPOSE

Antifungal

INDICATIONS & USAGE

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

WARNINGS

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.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Jock Powder

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.

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.

Foot Powder

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.

For athlete's foot: pay special attention to space between toes; wear well-fitting ventilated shoes and change socks at least once daily.

Supervise children in the use of this product.

Use daily for 4 weeks.

If the condition persists, consult a doctor.

This product is not effective on the scalp or nails.

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Dermachange Jock Powder, NDC: 83520-961-21

Dermachange Foot Powder, NDC: 83520-961-02

INGREDIENTS AND APPEARANCE

DERMACHANGE JOCK 
miconazole nitrate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83520-961
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83520-961-21	71 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/25/2023
2	NDC: 83520-961-02	71 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/25/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	10/25/2023

Labeler - Private label Beauty and Wellness (035014854)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(83520-961)