DERMACHANGE JOCK- miconazole nitrate powder 
Private label Beauty and Wellness

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Dermachange Foot and Jock Powder, 2% Miconazole Nitrate

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.

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.

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

Dermachange Jock Powder, NDC 83520-961-21

label

Dermachange Foot Powder, NDC 83520-961-02

LABEL

DERMACHANGE JOCK 
miconazole nitrate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83520-961
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STARCH, CORN (UNII: O8232NY3SJ)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
STARCH, RICE (UNII: 4DGK8B7I3S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83520-961-2171 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/2023
2NDC:83520-961-0271 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00510/25/2023
Labeler - Private label Beauty and Wellness (035014854)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(83520-961)

Revised: 3/2024
Document Id: 12eef049-76c8-1450-e063-6394a90a00ea
Set id: 12eef049-76c9-1450-e063-6394a90a00ea
Version: 1
Effective Time: 20240305
 
Private label Beauty and Wellness