Otc - Active Ingredient
Lemon grass 2X HPUS
Olive Extract 3X HPUS
Willow Bark Extract 3X HPUS
Roycederm Herpes Relief .cream
FDA Label NDC 85424-025
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Roycederm Llc for the product Roycederm Herpes Relief .cream (NDC 85424-025). 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 otc - active ingredient, otc - purpose, dosage & administration, warnings, otc - keep out of reach of children, otc - pregnancy or breast feeding, indications & usage, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiviral agent
Healingagent
Pain relief
Dosage & Administration
Temporarily relieves discomfort associated with genital herpes symptoms, including itching, tingling, burning, and skin irritation.
Warnings
For external use only.
- This product provides symptom relief only and is not intended to cure herpes.
- Use of this product willnot prevent future outbreaks.
- This product is not intended to reduce transmission ofherpes to others.
- This product does not protect against sexually transmitted infections (STIs).
- consult a healthcare professional before using this product.
- apply only to the affected areas.
- do not use in or near the eyes.
- do not share this product with anyone. This may spread the infection/virus.
- do not apply to severely irritated skin.
- symptoms worsen or persist after several days of use.
- excessive skin irritation or redness develops.
- signs of an allergic reaction occur.
Do not use If youare allergic to any ingredient in this product.
When using this product
Stop use and ask a doctor if
Otc - Keep Out Of Reach Of Children
If swallowed, get medical helpor contact the Poison Control Center right away.
Otc - Pregnancy Or Breast Feeding
ask a healthcare professional before use.
Indications & Usage
Adults and children12 years and older:
- Clean and dry the affected area before use.
- Apply a thin layer to the affected area.
- Reapply as needed throughout the day.
- For best results, use at the earliest sign of symptoms.
Children under 12 years:
Ask a doctor before use.
Other Safety Information
store at room temperature and out of direct sunlight.
Inactive Ingredient
Water, Aloe Barbadensis Leaf Water,Glycerin, Caprylic/Capric Triglyceride,Cetearyl Alcohol, Dimethicone,Glyceryl Stearate, Polysorbate 60,Panthenol, Sorbitan Stearate,PEG-100 Stearate, 1,2-Hexanediol,Hydroxyacetophenone, Beeswax,Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butylene Glycol,Squalane, Allantoin, Propanediol,1,2-Pentanediol, Avena Strigosa Seed Extract.
Otc - Questions
Visit www.roycederm.com
Tel:+1(307)461-0958
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