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
Purpose

External analgesic

Description

Drug Facts

Medication Information

Warnings

For external use only

Purpose

External analgesic

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
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.

Description

Drug Facts

Questions?

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

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.

Active Ingredient

Pramoxine HCL 1%

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

Warnings

For external use only

Purpose

External analgesic

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
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.

Questions?

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

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.

Active Ingredient (Active ingredient)

Pramoxine HCL 1%

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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:41.526951 · Updated: 2026-03-14T23:02:23.126471