Rugby Miconazole Nitrate 2%

Rugby Miconazole Nitrate 2%
SPL v2
SPL
SPL Set ID f420de00-408f-9a2c-e053-2995a90adced
Route
TOPICAL
Published
Effective Date 2023-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Cetostearyl Alcohol Dimethyl Sulfoxide Edetate Disodium Ethylparaben Glycerin Mineral Oil Laureth-30 Water Stearic Acid Trolamine Petrolatum Carbomer Homopolymer, Unspecified Type Glyceryl Mono And Dipalmitostearate Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-07

Description

Miconazole Nitrate 2%

Purpose

Anti-Fungal


Medication Information

Purpose

Anti-Fungal

Description

Miconazole Nitrate 2%

Uses
  • proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • relieves itching, scaling, cracking, burning and discomfort associated with these conditions.
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Section 51727-6

Inactive ingredients Carbomer, alcohol, cetostearyl alcohol, dimethyl sulfoxide, edetate disodium, ethylparaben, glycerol, mineral oil, mono and di glycerides, polyoxyethylene lauryl ether, purified water, stearic acid, triethanolamine, petrolatum.

Warnings

For external use only. Do not use if the safety-sealed tube is punctured or damaged.

Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with the eyes.

Stop use and ask a doctor if • irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm) • Irritation occurs, or if there is no improvement within 2 weeks (for jock itch).

Packaging

Directions

Clean 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 healthcare professional • Supervise children in the use of this product.

For athlete's foot: • Use daily for 4 weeks. If condition persists, consult a doctor • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoes • Change socks at least once daily.

For ringworm: Use daily for 4 weeks. If condition persists, consult a doctor.

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.

Drug Facts

Active Ingredient

Miconazole Nitrate 2%

Other Information

• Store at 15° - 30° c (59° - 86° f) • Lot number and expiration date see crimp of tube or see box. • To open: Unscrew cap, tear safety seal off.

Other Information

Distributed by:

Rugby Laboratories

Indianapolis, IN. 46268

800-616-2471

www.majorpharmaceuticals.com

This product is not manufactured or distributed by Wellspring Pharmaceutical Corporation owner of the registered trademark Micatin.


Structured Label Content

Uses
  • proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • relieves itching, scaling, cracking, burning and discomfort associated with these conditions.
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Section 51727-6 (51727-6)

Inactive ingredients Carbomer, alcohol, cetostearyl alcohol, dimethyl sulfoxide, edetate disodium, ethylparaben, glycerol, mineral oil, mono and di glycerides, polyoxyethylene lauryl ether, purified water, stearic acid, triethanolamine, petrolatum.

Purpose

Anti-Fungal

Warnings

For external use only. Do not use if the safety-sealed tube is punctured or damaged.

Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with the eyes.

Stop use and ask a doctor if • irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm) • Irritation occurs, or if there is no improvement within 2 weeks (for jock itch).

Packaging

Directions

Clean 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 healthcare professional • Supervise children in the use of this product.

For athlete's foot: • Use daily for 4 weeks. If condition persists, consult a doctor • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoes • Change socks at least once daily.

For ringworm: Use daily for 4 weeks. If condition persists, consult a doctor.

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.

Drug Facts

Active Ingredient (Active ingredient)

Miconazole Nitrate 2%

Other Information

• Store at 15° - 30° c (59° - 86° f) • Lot number and expiration date see crimp of tube or see box. • To open: Unscrew cap, tear safety seal off.

Other Information (Other information)

Distributed by:

Rugby Laboratories

Indianapolis, IN. 46268

800-616-2471

www.majorpharmaceuticals.com

This product is not manufactured or distributed by Wellspring Pharmaceutical Corporation owner of the registered trademark Micatin.


Advanced Ingredient Data


Raw Label Data

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