Active Ingredient(S)
ARTEMISIA EXTRACT 【FHFI】3%
Seborrheic Dermatitis And Psoriasis Cream
FDA Label NDC 81799-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ehy Holdings Llc for the product Seborrheic Dermatitis And Psoriasis Cream (NDC 81799-006). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Seborrheic
Use
Relieves and helps preventrecurrence of scalp: itching, flakingscaling, redness, and irritationassociated with psoriasis andseborrheic dermatitis.
Warnings
For external use only
Do Not Use
Do not use morethan 3 times daily. Children under12 years: ask a doctor
Otc - When Using
When using this productavoid contact with eyes.
Otc - Stop Use
condition worsens or does notimprove after regular use asdirected
Otc - Keep Out Of Reach Of Children
lf swallowed, get medical help orcontact a Poison Control Center (1-800-222-1222) right away.
Directions
Adult and children over 12 vears or old. Wash handsbefore and after applying the cream. Apply to affected area at the firstsign of blisters, sores, or tingling sensation. Rub in gently andthoroughly. Do not use more than 3 times daily. Children under 12years: ask a doctor
Other Information
Stor at room temperature and out of directsunlight.
Inactive Ingredients
Purified water, Artemisia extractsSophora Flavescens, Cnidium Monnieri (L) Cuss., Kochiascoparia, Dictamni Cortex, Smilax Glabra Roxb, SolidagoDecurrens, Phellodendron amurense Ruprecht., GleditsiaSinensis
Otc - Ask Doctor
than 3 times daily. Children under12 years: ask a doctor
Otc - Questions
Visit www.roycederm.com
Package Label - Principal Display Panel
81799-006-1
1
81799-006-1
2
* Please review the disclaimer below.
