Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID b97684ae-79d0-4208-b480-67794596ece7
Route
TOPICAL
Published
Effective Date 2021-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Water Mineral Oil Cetyl Alcohol White Wax Almond Oil Jojoba Oil Grape Seed Oil Decyl Oleate Coconut Oil Wheat Germ Oil Steareth-2 Steareth-21 Shea Butter Phenoxyethanol Triethylene Glycol Xanthan Gum .alpha.-tocopherol Butylated Hydroxytoluene Farnesol Cannabis Sativa Seed

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-08

Description

Salicylic Acid....2%

Purpose

Fungus treatment


Medication Information

Purpose

Fungus treatment

Description

Salicylic Acid....2%

Uses

Relieves and helps prevent

  • itching
  • irritation
  • redness due to jock itch
Warnings

For external use only

Directions
  • Apply to the affected area one to three times a day or as directed by a doctor.
  • Apply on clean and dry skin in circular motion.
  • To avoid running or dripping, lightly squeeze the tube.
Active Ingredient

Salicylic Acid....2%

Other Information

Store between 63°/80°F (17-30C)

Protect from humidity.

Inactive Ingredients

water, mineral oil, gms-se, Cetyl alcohol, cera alba, sweet almond oil, simmondsia chinensis seed oil, vitis vinifera seed oil, decyl oleate, coconut oil, brij-72, Trictum vulgaris (wheat) germ oil, butyrospermum parkii (shea) butter, brij-721, phenoxyethanol, triethylene glycol, Xanthan gum, BHT, Tocopheryl Acetate, Cannabis Sativa Seed Oil, farnesol

Principal Display Panel

NDC 70794-708-85

DERMAD ANTIFUNGAL Therapeutic Cream

RELIEVES

  • IRRITATION
  • ITCHING
  • REDNESS

FDA REGISTERED

DOES NOT CONTAIN STEROIDS, CORTISONE, FRAGRANCES AND COLORING

2.75 FL. OZ (81 mL)

When Using This Product

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with lukewarm water.

Keep Out of Reach of Children

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


Structured Label Content

Uses

Relieves and helps prevent

  • itching
  • irritation
  • redness due to jock itch
Purpose

Fungus treatment

Warnings

For external use only

Directions
  • Apply to the affected area one to three times a day or as directed by a doctor.
  • Apply on clean and dry skin in circular motion.
  • To avoid running or dripping, lightly squeeze the tube.
Active Ingredient

Salicylic Acid....2%

Other Information

Store between 63°/80°F (17-30C)

Protect from humidity.

Inactive Ingredients

water, mineral oil, gms-se, Cetyl alcohol, cera alba, sweet almond oil, simmondsia chinensis seed oil, vitis vinifera seed oil, decyl oleate, coconut oil, brij-72, Trictum vulgaris (wheat) germ oil, butyrospermum parkii (shea) butter, brij-721, phenoxyethanol, triethylene glycol, Xanthan gum, BHT, Tocopheryl Acetate, Cannabis Sativa Seed Oil, farnesol

Principal Display Panel

NDC 70794-708-85

DERMAD ANTIFUNGAL Therapeutic Cream

RELIEVES

  • IRRITATION
  • ITCHING
  • REDNESS

FDA REGISTERED

DOES NOT CONTAIN STEROIDS, CORTISONE, FRAGRANCES AND COLORING

2.75 FL. OZ (81 mL)

When Using This Product (When using this product)

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with lukewarm water.

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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