Aloe Vera Gel

Approved and Clinically Accepted Uses:

Dermatological Indications:

• Relief of minor burns, including sunburn and superficial thermal burns
• Management of skin irritation, including insect bites and contact dermatitis
• Supportive treatment for wound healing (minor cuts, abrasions, and postoperative wounds)
• Soothing and moisturizing treatment for eczema, psoriasis, and atopic dermatitis
• Adjunctive therapy in acne management (non-inflammatory and mild inflammatory forms)
• Relief of radiation-induced skin damage

Cosmetic and Preventive Indications:

• Daily skin hydration and moisturization
• Prevention of dry, flaky, or cracked skin
• Maintenance of skin barrier integrity and elasticity
• Prevention of premature aging caused by oxidative stress or sun exposure

Adults:

• Topical Use: Apply a thin layer of Aloe Vera Gel directly to the affected skin area 2–3 times daily or as needed.
• For burns/sunburn: Apply liberally to the affected area every 4–6 hours.
• For dry or irritated skin: Use once or twice daily as part of skincare regimen.

Pediatrics (≥2 years):

• Apply a small amount to affected skin area 1–2 times daily under adult supervision. Not recommended for infants under 2 years unless prescribed.

Elderly:

• No dose adjustment needed. Apply as in adults. Monitor for skin thinning or sensitivity.

Special Populations:

• Renal or Hepatic Impairment: No dose adjustment required as systemic absorption is negligible.

Route of Administration:

• Topical only. Not intended for oral, ophthalmic, or intravaginal use.

Aloe Vera Gel contains a range of biologically active compounds including polysaccharides (mainly acemannan), glycoproteins, vitamins (A, C, E), enzymes, and amino acids. These constituents act synergistically to promote epithelial regeneration, anti-inflammatory activity, and wound healing. Acemannan stimulates fibroblast proliferation and enhances collagen synthesis, while antioxidant vitamins neutralize reactive oxygen species (ROS), protecting skin from oxidative damage. The gel also inhibits cyclooxygenase (COX) pathways, reducing prostaglandin production and thus inflammation. Moisturizing action is achieved through water retention in the stratum corneum, improving skin hydration and barrier function.

Absorption:

• Minimal systemic absorption through intact skin. Higher absorption may occur if applied to damaged or broken skin.

Distribution:

• Primarily acts locally at the site of application.

Metabolism:

• Metabolized locally in the skin. Systemic metabolic pathways are not significantly involved.

Excretion:

• Negligible systemic excretion due to low absorption.

Onset of Action:

• Cooling and soothing effect is usually felt within minutes of application.

Half-life/Bioavailability:

• Not applicable for topical non-systemic use.

• Pregnancy: Aloe Vera Gel (topical) is considered safe during pregnancy when used on intact skin. It should not be used over large areas or broken skin due to limited safety data.
• Lactation: Safe for use during breastfeeding. Avoid application on or near the nipple area to prevent infant ingestion.
• Note: Oral Aloe Vera is not recommended during pregnancy due to potential uterine stimulation, but topical gel use remains acceptable when used appropriately.

• Primary Therapeutic Class: Herbal Topical Agent
• Sub-class: Skin Soothing, Moisturizing, and Wound Healing Agent

• Known hypersensitivity or allergy to Aloe Vera or any of the gel’s components
• Application on deep or infected wounds without medical supervision
• Use on severely damaged or ulcerated skin unless prescribed
• Children under 2 years (without physician direction)

• For external use only. Avoid contact with eyes and mucous membranes.
• Discontinue use if signs of hypersensitivity appear (e.g., rash, redness, itching, swelling).
• Do not apply to large or broken skin surfaces unless advised by a physician.
• In rare cases, delayed allergic reactions may occur with prolonged use.
• Use with caution in patients with known plant-based allergies, especially to Liliaceae family (e.g., garlic, onions, tulips).
• Clinical monitoring is not routinely required but is advised in extensive or long-term use.

Common (Mild):

• Transient stinging or burning sensation upon application
• Local itching or redness
• Mild dryness or peeling (rare with prolonged use)

Uncommon/Rare:

• Allergic contact dermatitis
• Urticaria or swelling
• Photosensitivity or rash upon sun exposure (very rare)

Serious (Very Rare):

• Anaphylaxis (extremely rare, usually in individuals with severe Aloe allergy)

• Drug–Drug Interactions: None known with topical use.
• Drug–Food Interactions: Not applicable.
• Drug–Alcohol Interactions: No known interactions.
• Enzyme Involvement: Not metabolized via hepatic CYP450 system; interactions through enzymatic inhibition or induction are unlikely.

• No major changes in Aloe Vera Gel use have been issued by regulatory bodies such as the FDA, EMA, or WHO.
• Continued recognition in dermatology and cosmetic dermatology for hydration and wound-healing properties.
• Some dermatology guidelines recommend Aloe Vera Gel as a supportive, non-pharmacologic therapy in the management of mild atopic dermatitis and superficial burns.

• Temperature: Store between 20°C to 25°C (68°F to 77°F). Acceptable range: 15°C–30°C.
• Humidity: Store in a dry place. Avoid exposure to excessive moisture.
• Light Protection: Protect from direct sunlight to preserve active components.
• Handling Instructions:
• Do not freeze.
• Keep cap tightly closed when not in use.
• For multi-use tubes or jars, avoid contamination by not touching the nozzle/opening to the skin.