Pro-ex

Pro-ex
SPL v13
SPL
SPL Set ID be06dd85-e342-4f07-b0e4-c49b3f6b3b4b
Route
TOPICAL
Published
Effective Date 2024-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (0.01 g)
Inactive Ingredients
Aloe Vera Leaf Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Cetyl Alcohol Dmdm Hydantoin Glyceryl Monostearate Methylparaben Mineral Oil Polysorbate 20 Propylparaben Stearic Acid Trolamine Edetate Trisodium Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2008-01-22

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

Uses
  • cures most athlete's foot, jock itch, and ringworm
  • relieves itching, burning, cracking, scaling and discomfort
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Section 50570-1

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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

For external use only.

Avoid contact with eyes.

Directions
  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in use of this product
  • for athlete's foot, pay special 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 doctor
  • this product is not effective on scalp or nails
Active Ingredient

Clotrimazole 1%

Other Information
  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
Inactive Ingredients

aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA

Questions Or Comments?

866-323-0107 or www.natureplex.com

Stop Use and Ask A Doctor If
  • irritation occurs
  • there is no improvement within 4 weeks for athlete's foot and ringworm or 2 weeks for jock itch
Principal Display Panel 42 G Tube Carton

Natureplex™

NATUREPLEX

QUALITY

GUARANTEED

Pro-Ex

clotrimazole cream

NET WT. 1.5 Oz.

(42g)


Structured Label Content

Uses
  • cures most athlete's foot, jock itch, and ringworm
  • relieves itching, burning, cracking, scaling and discomfort
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Section 50570-1 (50570-1)

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antifungal

Warnings

For external use only.

Avoid contact with eyes.

Directions
  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in use of this product
  • for athlete's foot, pay special 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 doctor
  • this product is not effective on scalp or nails
Active Ingredient (Active ingredient)

Clotrimazole 1%

Other Information (Other information)
  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA

Questions Or Comments? (Questions or comments?)

866-323-0107 or www.natureplex.com

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation occurs
  • there is no improvement within 4 weeks for athlete's foot and ringworm or 2 weeks for jock itch
Principal Display Panel 42 G Tube Carton (PRINCIPAL DISPLAY PANEL - 42 g Tube Carton)

Natureplex™

NATUREPLEX

QUALITY

GUARANTEED

Pro-Ex

clotrimazole cream

NET WT. 1.5 Oz.

(42g)


Advanced Ingredient Data


Raw Label Data

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