PRAMOXINE: 66 Adverse Event Reports & Safety Profile
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Active Ingredient: PRAMOXINE HYDROCHLORIDE · Route: TOPICAL · Manufacturer: Publix · HUMAN OTC DRUG · FDA Label: Available
First Report: 2015 · Latest Report: 20250101
What Are the Most Common PRAMOXINE Side Effects?
All PRAMOXINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Cough | 18 | 27.3% | 0 | 0 |
| Dyspnoea | 18 | 27.3% | 0 | 0 |
| Iron deficiency anaemia | 18 | 27.3% | 0 | 2 |
| Disease recurrence | 17 | 25.8% | 0 | 0 |
| Asthma | 16 | 24.2% | 0 | 0 |
| Candida infection | 16 | 24.2% | 0 | 0 |
| Chest discomfort | 16 | 24.2% | 0 | 0 |
| Chronic sinusitis | 16 | 24.2% | 0 | 0 |
| Deep vein thrombosis | 16 | 24.2% | 0 | 0 |
| Diastolic dysfunction | 16 | 24.2% | 0 | 0 |
| Diverticulum | 16 | 24.2% | 0 | 0 |
| Dyspnoea exertional | 16 | 24.2% | 0 | 0 |
| Eczema | 16 | 24.2% | 0 | 0 |
| Embolism venous | 16 | 24.2% | 0 | 0 |
| Emphysema | 16 | 24.2% | 0 | 0 |
| Female genital tract fistula | 16 | 24.2% | 0 | 0 |
| Fungal infection | 16 | 24.2% | 0 | 0 |
| Gastrooesophageal reflux disease | 16 | 24.2% | 0 | 0 |
| Hiatus hernia | 16 | 24.2% | 0 | 0 |
| Lower respiratory tract infection | 16 | 24.2% | 0 | 0 |
Who Reports PRAMOXINE Side Effects? Age & Gender Data
Gender: 78.6% female, 21.4% male. Average age: 57.2 years. Most reports from: US. View detailed demographics →
Is PRAMOXINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2015 | 3 | 0 | 3 |
| 2016 | 1 | 0 | 0 |
| 2017 | 3 | 1 | 0 |
| 2018 | 1 | 0 | 0 |
| 2019 | 1 | 0 | 0 |
| 2021 | 2 | 0 | 1 |
| 2022 | 1 | 0 | 0 |
| 2024 | 1 | 0 | 0 |
| 2025 | 1 | 0 | 0 |
What Is PRAMOXINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 26 |
| Pruritus | 12 |
Official FDA Label for PRAMOXINE
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses ■ Dries the oozing and weeping of poison: ■ ivy ■ oak ■ sumac ■ For the temporary relief of pain and itching associated with ■ minor skin irritations ■ rashes due to poison ivy, poison oak, or poison sumac ■ minor burns ■ sunburn ■ minor cuts ■ scrapes ■ insect bites
Dosage & Administration
Directions adults and children 12 years and older Unfold towelette and gently pat or wipe external vaginal area from front to back. Use each towelette only once and then throw away. Apply to affected area not more than 3 to 4 times daily. Do not flush. children under 12 years consult a doctor
Directions adults and children 12 years and older Unfold towelette and gently pat or wipe external vaginal area from front to back. Use each towelette only once and then throw away. Apply to affected area not more than 3 to 4 times daily. Do not flush. children under 12 years consult a doctor
Known Adverse Reactions
ADVERSE REACTION DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007 ©TOPCO VIJA0622 Questions? 1-888-423-0139 [email protected] www.topcarebrand.com Visit here for more information: http:/topbrnds.com/4901jl Quality Guaranteed
Warnings
Warnings For external use only When using this product
- do not exceed the recommended daily dosage unless directed by a doctor
- do not put this product into the rectum by using fingers or any mechanical device or applicator
- do not insert any part of the aerosol container into the rectum Stop use and ask a doctor if
- rectal bleeding occurs
- condition worsens or does not improve within 7 days
- allergic reaction occurs to the ingredients in this product
- symptom being treated does not subside
- redness, irritation, swelling, pain or other symptoms develop or increase If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Active Ingredient
Active ingredients Purpose Pramoxine HCl 1.0% (w/w)
External Analgesic Zinc Acetate
0.12 % (w/w)
Skin
Protectant
Inactive Ingredients
Inactive Ingredients: Aloe Barbadensis Leaf Extract, *Aloe Barbadensis Leaf Juice, Althaea officinalis Root Extract, Avena Sativa (Oat)
Kernel
Extract, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria)
Flower
Extract, Citric Acid, Cocamidopropyl PG-Dimonium Chloride Phosphate, Cocos Nucifera (Coconut)
Fruit
Extract, Cucumis Sativus (Cucumber)
Fruit
Extract, Disodium Cocoamphodiacetate, Ethylhexylglycerin, Euterpe Oleracea Fruit Extract, Fragrance, Glycerin, Hamamelis Virginiana (Witch Hazel) Water, Helianthus Annuus (Sunflower)
Seed
Oil, *Honey, Lactobacillus, Lactobacillus Ferment, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Polyglyceryl-4 Caprate, Punica Granatum Fruit Extract, Rosa Centifolia Flower Water, Sodium Chloride, Tetrasodium Glutamate Diacetate Tocopheryl Acetate, *Vinegar (Apple Cider), Water *Organic Ingredients