Prosoria Anti-itch Scalp Moisturizer

Prosoria Anti-itch Scalp Moisturizer
SPL v2
SPL
SPL Set ID 3c4b9515-f435-4227-a347-d6508778426d
Route
TOPICAL
Published
Effective Date 2024-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (0.9 g)
Inactive Ingredients
Water Cetyl Alcohol Copaifera Officinalis Resin Tetrahydrodiferuloylmethane Glyceryl Stearate Se Peg-100 Stearate Phenoxyethanol Edetate Disodium Anhydrous Sodium Citrate, Unspecified Form Stearic Acid Glycerin Stearyl Alcohol .alpha.-tocopherol Acetate Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-01

Description

Drug Facts

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Drug Facts

Use

for the temporary relief of itching associated with minor skin irritations

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 immediately.

Section 50567-7

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Warnings

For external use only

Directions
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor
Questions?

Visit www.prosoria.com or call toll-free 1-833-776-7483 Mon – Fri, 8am – 5pm CT.

Active Ingredient

Pramoxine HCL 1%

Inactive Ingredients

Water, White Petrolatum, Glycerin, PEG-100 Stearate, Glyceryl Stearate SE, Stearic Acid, Copaifera Coriacea Resin Oil, Tetrahydrodiferuloylmethane, Cetyl Alcohol, Stearyl Alcohol, Phenoxyethanol, Vitamin E (Tocopheryl acetate), Xanthan Gum, Sodium Citrate, Disodium EDTA.

Stop Use and Consult A Doctor If
  • the condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.
Principal Display Panel 90 Ml Bottle Label

moisturizes

relieves itching

prosoriä

anti-itch

moisturizer

Pramoxine Hydrochloride 1%

external analgesic

3 FL OZ (90mL)


Structured Label Content

Use

for the temporary relief of itching associated with minor skin irritations

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 immediately.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Purpose

External analgesic

Warnings

For external use only

Directions
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor
Questions?

Visit www.prosoria.com or call toll-free 1-833-776-7483 Mon – Fri, 8am – 5pm CT.

Active Ingredient (Active ingredient)

Pramoxine HCL 1%

Inactive Ingredients (Inactive ingredients)

Water, White Petrolatum, Glycerin, PEG-100 Stearate, Glyceryl Stearate SE, Stearic Acid, Copaifera Coriacea Resin Oil, Tetrahydrodiferuloylmethane, Cetyl Alcohol, Stearyl Alcohol, Phenoxyethanol, Vitamin E (Tocopheryl acetate), Xanthan Gum, Sodium Citrate, Disodium EDTA.

Stop Use and Consult A Doctor If (Stop use and consult a doctor if)
  • the condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.
Principal Display Panel 90 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 90 mL Bottle Label)

moisturizes

relieves itching

prosoriä

anti-itch

moisturizer

Pramoxine Hydrochloride 1%

external analgesic

3 FL OZ (90mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)