Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID d872a4ee-554e-4bca-acb1-3bbf57dc690b
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 Glyceryl Monostearate Cetyl Alcohol Yellow 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 Hyaluronic Acid Calendula Officinalis Flower Linseed Oil Cannabis Sativa Seed Oil

Identifiers & Packaging

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

Description

Salicylic Acid....2%

Purpose

Atopic Dematitis treatment


Medication Information

Purpose

Atopic Dematitis 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, Glyceryl Stearate, Cetyl Alcohol, Bees Wax, Sweet Almond Oil, Jojoba Seed Oil. Grape Seed Oil, Decyl Qleate, Hyaluronlc Acid, Oeothera Biennis Oil, Calandula Oil, Coconut Oil, Steareth-2, Trictum Vulgaris (Wheat) Germ Oil, Linum Usitatissimum Seed Oil, Butyrospermum Parkii (Shea Butter), Steareth-21, Phenoxyethanol and Triethylene Glycol, Xanthan Gum, BHT, Tocopheryl Acetate, Cannabis Sativa Seed Oil, Farnesol.

Principal Display Panel

NDC 70794-101-28

DERMAD ATOPICE DERMATITIS 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

Atopic Dematitis 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, Glyceryl Stearate, Cetyl Alcohol, Bees Wax, Sweet Almond Oil, Jojoba Seed Oil. Grape Seed Oil, Decyl Qleate, Hyaluronlc Acid, Oeothera Biennis Oil, Calandula Oil, Coconut Oil, Steareth-2, Trictum Vulgaris (Wheat) Germ Oil, Linum Usitatissimum Seed Oil, Butyrospermum Parkii (Shea Butter), Steareth-21, Phenoxyethanol and Triethylene Glycol, Xanthan Gum, BHT, Tocopheryl Acetate, Cannabis Sativa Seed Oil, Farnesol.

Principal Display Panel

NDC 70794-101-28

DERMAD ATOPICE DERMATITIS 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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