Restoral

Restoral
SPL v1
SPL
SPL Set ID 6e9bb6aa-2b24-84fb-e053-2991aa0ae6ef
Route
TOPICAL
Published
Effective Date 2018-06-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (3 g)
Inactive Ingredients
Sodium Chloride Aloe Vera Leaf Steareth-21 Glyceryl Monostearate Water Cannabis Sativa Seed Oil Shea Butter Petrolatum .alpha.-tocopherol Acetate Lavender Oil Glycyrrhizinate Dipotassium Trolamine Salicylate Levomenol Edetate Disodium Anhydrous Cetyl Alcohol Calendula Officinalis Flower Peg-100 Stearate Glycerin Niacinamide Allantoin Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-06-14

Description

Salicylic Acid, 2%


Medication Information

Indications and Usage

Directions

  • apply to affected areas one to four times daily or as directed by a doctor
  • massage a liberal amount of the product into skin until thoroughly absorbed
Dosage and Administration

Directions

  • apply to affected areas one to four times daily or as directed by a doctor
  • massage a liberal amount of the product into skin until thoroughly absorbed
Description

Salicylic Acid, 2%

Section 50565-1

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

Section 51727-6

Inactive ingredients

water, glyceryl stearate, PEG-100 stearate, glycerin, niacinamide, calendula officinalis flower oil, cannabis sativa seed oil, cetyl alcohol, butyrospermum parkii (shea butter), petrolatum, allantoin, steareth-21, tocopheryl acetate (vitamin E), lavandula angustifolia (lavender) oil, xanthan gum, dipotassium glycyrrhizate, aloe barbadensis leaf juice, triethanolamine, bisabolol, disodium EDTA, maris sal (dead sea mineral water).

Section 51945-4

Section 55105-1

Uses

Relieves and helps prevent recurrence of skin itching

  • irritation
  • redness
  • flaking
  • scaling

due to psoriasis and seborrheic dermatitis

Section 55106-9

Salicylic Acid, 2%


Structured Label Content

Indications and Usage (34067-9)

Directions

  • apply to affected areas one to four times daily or as directed by a doctor
  • massage a liberal amount of the product into skin until thoroughly absorbed
Dosage and Administration (34068-7)

Directions

  • apply to affected areas one to four times daily or as directed by a doctor
  • massage a liberal amount of the product into skin until thoroughly absorbed
Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

water, glyceryl stearate, PEG-100 stearate, glycerin, niacinamide, calendula officinalis flower oil, cannabis sativa seed oil, cetyl alcohol, butyrospermum parkii (shea butter), petrolatum, allantoin, steareth-21, tocopheryl acetate (vitamin E), lavandula angustifolia (lavender) oil, xanthan gum, dipotassium glycyrrhizate, aloe barbadensis leaf juice, triethanolamine, bisabolol, disodium EDTA, maris sal (dead sea mineral water).

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses

Relieves and helps prevent recurrence of skin itching

  • irritation
  • redness
  • flaking
  • scaling

due to psoriasis and seborrheic dermatitis

Section 55106-9 (55106-9)

Salicylic Acid, 2%


Advanced Ingredient Data


Raw Label Data

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