aloe vesta tm

aloe vesta tm
SPL v1
SPL
SPL Set ID 5a200604-de24-4d7d-82bb-b19afaaac97c
Route
topical
Published
Effective Date 2016-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
miconazole (2.82 g)
Inactive Ingredients
aloe vera leaf bis-diglyceryl polyacyladipate-2 mineral oil petrolatum

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2016-06-09

Purpose

Antifungal

Description

Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). Relieves itching, scaling, cracking, burning, redness, soreness, irritation, and discomfort that accompany these conditions. For treatment of most superficial skin infections caused by yeast (Candida albicans). Follow a physician's instructions when treating Candida.


Medication Information

Warnings

For external use only.

Do not use on children under 2 years of age unless directed by a physician.

When using this product, avoid contact with eyes. If irritation occurs or if there is no improvement within 2 weeks for jock itch, or 4 weeks for athlete's foot or ringworm, discontinue use and consult a physician.

Uses
  • Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
  • Relieves itching, scaling, cracking, burning, redness, soreness, irritation, and discomfort that accompany these conditions.
  • For treatment of most superficial skin infections caused by yeast (Candida albicans).
  • Follow a physician's instructions when treating Candida.
Purpose

Antifungal

Directions

Clean the affected area and dry thoroughly.

  • Apply a thin layer of ointment over affected area twice daily (morning and night) or as directed by a physician.
  • Supervise children in use of this product.

For athlete's foot: Pay close 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 physician.
  • This product is not effective on the scalp or nails.
Inactive Ingredients

Aloe Barbadensis Leaf Extract, Bis-Diglyceryl Polyacladipate-2, Mineral Oil, Petrolatum

Description

Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). Relieves itching, scaling, cracking, burning, redness, soreness, irritation, and discomfort that accompany these conditions. For treatment of most superficial skin infections caused by yeast (Candida albicans). Follow a physician's instructions when treating Candida.

Section 42229-5

CLEAR ANTIFUNGALOINTMENT

  • CHG Compatible
  • Cures Most:

     -Athlete's Foot

     -Ringworm

     -Jock Itch

     -Superficial Yeast Infections

  • Fragrance & Dye Free

with 2 % Miconazole Nitrate and a Natural Botanical

Manufactured for:

ConvaTec

ConvaTec Inc.

Greensboro, NC 27409

1-800-422-8811

www.convatec.com

Made in USA

Section 44425-7

Store at 15°C -30°C (59°F - 86°F)

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or consult a Poison Control Center right away.

Packaging

Drug Facts

Active Ingredient

Miconazole Nitrate 2%


Structured Label Content

Warnings

For external use only.

Do not use on children under 2 years of age unless directed by a physician.

When using this product, avoid contact with eyes. If irritation occurs or if there is no improvement within 2 weeks for jock itch, or 4 weeks for athlete's foot or ringworm, discontinue use and consult a physician.

Uses
  • Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
  • Relieves itching, scaling, cracking, burning, redness, soreness, irritation, and discomfort that accompany these conditions.
  • For treatment of most superficial skin infections caused by yeast (Candida albicans).
  • Follow a physician's instructions when treating Candida.
Purpose

Antifungal

Directions

Clean the affected area and dry thoroughly.

  • Apply a thin layer of ointment over affected area twice daily (morning and night) or as directed by a physician.
  • Supervise children in use of this product.

For athlete's foot: Pay close 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 physician.
  • This product is not effective on the scalp or nails.
Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Extract, Bis-Diglyceryl Polyacladipate-2, Mineral Oil, Petrolatum

Section 42229-5 (42229-5)

CLEAR ANTIFUNGALOINTMENT

  • CHG Compatible
  • Cures Most:

     -Athlete's Foot

     -Ringworm

     -Jock Itch

     -Superficial Yeast Infections

  • Fragrance & Dye Free

with 2 % Miconazole Nitrate and a Natural Botanical

Manufactured for:

ConvaTec

ConvaTec Inc.

Greensboro, NC 27409

1-800-422-8811

www.convatec.com

Made in USA

Section 44425-7 (44425-7)

Store at 15°C -30°C (59°F - 86°F)

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or consult a Poison Control Center right away.

Packaging

Drug Facts

Active Ingredient (Active ingredient)

Miconazole Nitrate 2%


Advanced Ingredient Data


Raw Label Data

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