Simorosmary

Product Form: Cream
Packaging: 1 tube (30 g) with a patient information leaflet enclosed in a cardboard box.

Active Ingredients (Per 30 g of Cream)

• Rosemary Oil (Rosmarinus officinalis): 0.6 g
• Onion Tincture (Allium cepa): 0.249 g
• Wood Sorrel Tincture (Oxalis acetosella): 0.15 g
• Rue Tincture (Ruta graveolens): 0.249 g
• Infusion of Comfrey (Symphytum officinale): 0.06 g
• Arnica Flower Tincture (Arnica montana): 0.027 g
• Arnica Root Tincture (Arnica montana): 0.006 g
• St. John’s Wort Oil Extract (Hypericum perforatum): 0.06 g
• Arnica Oil Extract (Arnica montana): 0.087 g
• Camphor (Cinnamomum camphora): 0.6 g
• Lemon Oil (Citrus limon): 0.339 g

Other Ingredients: Paraffin, cetyl alcohol, stearic acid, beeswax, methylparaben, propylparaben, lanolin, glycerin, and water.

Standardization: Each 30 g contains 2.85 mg total sesquiterpene lactones.

Indications

SimoRosmary cream is formulated to:

• Relieve tendon inflammation, muscle strain, sprains, and sports injuries.
• Reduce inflammation and bruising in bony areas.
• Alleviate pain and promote healing of injured tissues.

Dosage and Administration

• Application Method: Apply a sufficient amount of the cream to the affected area and repeat 3–4 times daily.

Precautions and Contraindications

1. Avoid use:
   • On open wounds or damaged skin.
   • In individuals with known hypersensitivity to herbal products without prior sensitivity testing.
   • In areas with cuts or injuries.
2. Pregnancy and Lactation:
   • Not recommended due to insufficient safety data.
3. Pediatric Use:
   • Not suitable for children under 6 years old.

Sensitivity Test:
Before first use, apply a small amount to the inner forearm near the wrist. If no redness, itching, or rash occurs within 12–24 hours, proceed with full application.

Precautions and Contraindications

1. Avoid use:
   • On open wounds or damaged skin.
   • In individuals with known hypersensitivity to herbal products without prior sensitivity testing.
   • In areas with cuts or injuries.
2. Pregnancy and Lactation:
   • Not recommended due to insufficient safety data.
3. Pediatric Use:
   • Not suitable for children under 6 years old.

Sensitivity Test:
Before first use, apply a small amount to the inner forearm near the wrist. If no redness, itching, or rash occurs within 12–24 hours, proceed with full application.

Side Effects

• Topical Application:
  • Generally non-irritating.
  • In rare cases, hypersensitive individuals may experience skin reactions such as redness, burning, itching, or rashes.

Drug Interactions

• No reported interactions with concurrent medications.

Pharmacological Effects and Mechanism of Action

1. Rosemary (Rosmarinus officinalis):
   • Contains volatile oils (1,8-cineole, borneol, camphor, α-pinene, β-pinene) and polyphenolic compounds such as rosmarinic acid.
   • Anti-inflammatory effects are primarily attributed to rosmarinic acid, which reduces cytokine activity and provides protective effects against dermatitis.
2. Rue (Ruta graveolens):
   • Contains alkaloids (arborine, arborinine) and furanocoumarins (rutamarin, bergapten).
   • Exhibits anti-inflammatory and reversible antispasmodic properties.
3. Onion (Allium cepa):
   • Flavonoids inhibit cyclooxygenase-2 (COX-2) transcription and reduce nitric oxide and TNF-α production, providing anti-inflammatory effects.
4. Camphor (Cinnamomum camphora):
   • Suppresses cytokine production and inhibits inflammatory mediators like prostaglandins and nitric oxide.
   • Reduces expression of COX-2 mRNA.
5. St. John’s Wort (Hypericum perforatum):
   • Exhibits anti-inflammatory and capillary permeability-modulating properties due to flavonoids.
   • Hypericin enhances tissue oxygenation and improves energy metabolism.
6. Arnica (Arnica montana):
   • Sesquiterpene lactones provide anti-inflammatory and analgesic properties.

Storage Conditions

• Store in a cool, dry place below 25°C, away from light and moisture.
• Keep the tube tightly closed after each use.
• Keep out of reach of children.