ALLANTOIN: 157 Adverse Event Reports & Safety Profile
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Route: TOPICAL · Manufacturer: Genuine Virgin Aloe Corporation · HUMAN OTC DRUG · FDA Label: Available
First Report: 20120605 · Latest Report: 20240712
What Are the Most Common ALLANTOIN Side Effects?
All ALLANTOIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Hyponatraemia | 108 | 68.8% | 108 | 75 |
| Condition aggravated | 107 | 68.2% | 104 | 75 |
| General physical health deterioration | 105 | 66.9% | 105 | 72 |
| Stress | 105 | 66.9% | 105 | 72 |
| Multiple organ dysfunction syndrome | 104 | 66.2% | 104 | 71 |
| Sepsis | 103 | 65.6% | 102 | 70 |
| Somnolence | 103 | 65.6% | 103 | 74 |
| Abdominal distension | 101 | 64.3% | 101 | 69 |
| Vomiting | 100 | 63.7% | 99 | 68 |
| Off label use | 99 | 63.1% | 99 | 73 |
| Appendicitis | 98 | 62.4% | 98 | 66 |
| Ascites | 98 | 62.4% | 98 | 66 |
| Ventricular fibrillation | 98 | 62.4% | 98 | 66 |
| Abdominal pain | 97 | 61.8% | 97 | 65 |
| Appendicolith | 97 | 61.8% | 97 | 65 |
| Constipation | 95 | 60.5% | 95 | 63 |
| Nausea | 95 | 60.5% | 95 | 63 |
| Cardiogenic shock | 94 | 59.9% | 94 | 62 |
| Blood phosphorus increased | 92 | 58.6% | 92 | 62 |
| Dry mouth | 92 | 58.6% | 92 | 64 |
Who Reports ALLANTOIN Side Effects? Age & Gender Data
Gender: 3.9% female, 96.1% male. Average age: 79.2 years. Most reports from: CA. View detailed demographics →
Is ALLANTOIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 2 | 0 | 0 |
| 2015 | 1 | 0 | 0 |
| 2017 | 1 | 0 | 0 |
| 2019 | 1 | 0 | 0 |
| 2020 | 42 | 42 | 36 |
| 2021 | 9 | 9 | 2 |
| 2022 | 5 | 0 | 1 |
| 2024 | 2 | 0 | 0 |
What Is ALLANTOIN Used For?
| Indication | Reports |
|---|---|
| Constipation | 107 |
| Off label use | 61 |
| Intentional product misuse | 58 |
| Product used for unknown indication | 38 |
| Scar | 5 |
ALLANTOIN vs Alternatives: Which Is Safer?
Official FDA Label for ALLANTOIN
Official prescribing information from the FDA-approved drug label.
Drug Description
Description: Scartrate™ Cream contains 50 mg of Dimethicone and 22.5 mg of Allantoin per gram in a vehicle consisting of Aleurites Moluccana (Kukui)
Seed
Oil, Aloe Barbadensis Leaf (Aloe Vera) Juice, Aqua (Purified Water), Butylene Glycol, Carthamus Tinctorius (Safflower) Oil, Cetyl Alcohol, Dimethicone Crosspolymer, Disodium EDTA, DL-alpha Tocopheryl Acetate, GenRx® Complex (proprietary blend), Glycerin, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, sh-Polypeptide-121, Sodium Hydroxide, Stearic Acid, and Fragrance.
FDA Approved Uses (Indications)
How to Apply:Our formula is designed to be gentle for the delicate eye area.Gently place the mask on the entire eye contour area, ensuring asmooth fit. The unique cut-out design helps protect your eyes. Ifany essence gets into the eyes, simply rinse with water. After removing the mask, gently massage anyremaining essence into the skin. For a fresh finish,we recommend lightly rinsing the eye area withwater and proceeding with your regular skincareroutine.
Dosage & Administration
Directions
- squeeze tube to dispense
- blend well until green tint disappears
- rub in gently Adults and children 2 years of age and older | Apply to affected area not more than 3 to 4 times daily Children under 12 years of age | Should be supervised in the use of this product Children under 2 years of age | Ask a physician Other information
- do not use if the package is torn, cut or otherwise damaged
- store at 15-30ºC (59-86º) under dry conditions
- this is a personal care item and should be used by one individual only
Contraindications
Contraindications: Do not use on deep or puncture wounds, animal bites, or serious burns.
Known Adverse Reactions
Adverse Reactions: No adverse reactions have been reported under normal conditions of use. If you experience any unusual reactions, discontinue use and consult your licensed healthcare practitioner.
Warnings
Warnings: 1. If you notice any unusual symptoms or side effects such as redness, swelling, or itching in the area where the cosmetic product was applied, particularly after direct sunlight exposure during or after use, seek advice from a specialist or health care professional 2. Do not apply on broken or irritated skin. 3. Precautions for Safe Handling: a. Keep out of reach of children b. Store in a cool, dry place and away from direct sunlight. 4. Use exclusively on the external genital area; avoid internal vaginal application 5. Follow the recommended usage instructions on the product packaging 6. Avoid application on children under 3 years old 7. Avoid use during pregnancy and refrain from application around the external genital area immediately before childbirthPrecautions for Safe Handling: a. Keep out of reach of children
Precautions
1.For External Use Only. 2.Avoid Direct Contact with Eyes. 3.If the product gets into your eyes, rinse immediately with plenty of water. 4.Discontinue Use if Irritation Occurs: If redness, itching, or irritation develops, stop use and consult a dermatologist. 5.Do Not Apply on Broken or Irritated Skin.
Keep
Out of Reach of Children.
Active Ingredient
Active Ingredient/Purpose Allantoin 0.5%........................Skin Protectant Benzethonium Chloride 0.1%............Antiseptic Uses helps protect skin and supports healing of minor cuts, scrapes, burns and wounds, including pressure sores, diabetic ulcers, cracked skin and lips topical antiseptic to help decrease the risk of skin infections
Inactive Ingredients
Inactive ingredients Annona Cherimola Fruit Extract, Aqua/Eau/Water, Ascorbic Acid, Benzoic Acid, Boswellia Serrata Extract, Butylene Glycol, Caprylyl Glycol, Chlorphenesin, Chlorphenesin, Citric Acid, Coco-Caprylate/Caprate, Decyl Glucoside, Dehydroacetic Acid, Dimethylacrylamide/Acrylic Acid/Polystyrene Ethyl Methacrylate Copolymer, Dipotassium Glycyrrhizate, Disodium Lauriminodipropionate Tocopheryl Phosphates, Glycerin, Glycyrrhetinic Acid, Helianthus Annuus (Sunflower)
Seed
Oil, Hexylene Glycol, Honey Extract/Mel Extract/Extrait De Miel, Hydrogenated Polyisobutene, Isododecane, Linoleic Acid, Linolenic Acid, Ocimum Sanctum Leaf Extract, Oleic Acid, Oligopeptide-10, Oryza Sativa (Rice)
Bran
Extract, Palmitic Acid, Panthenol, PEG-40 Stearate, Phenoxyethanol, Phenyl Trimethicone, Phenylpropanol, Phoenix Dactylifera (Date)
Seed
Extract, Phospholipids, Polyglyceryl-10 Stearate, Polysilicone-11, Propanediol, Sodium Acrylates Copolymer, Sodium Benzoate, Sodium Citrate, Sodium Dehydroacetate, Stearic Acid, Synthetic Fluorphlogopite, Tetrapeptide-16, Tin Oxide, Titanium Dioxide, Titanium Dioxide, Tocopherol, Xanthan Gum.