OTC - ACTIVE INGREDIENT SECTION
Active ingredient Purpose
Pramoxine Hydrochloride 1.0%.............External Analgesic
Active ingredient Purpose
Pramoxine Hydrochloride 1.0%.............External Analgesic
Uses
For temporary relief of pain and itching associated with
• minor burns • sunburn • minor cuts • scrapes • insect bites
• minor skin irritations
Warnings
For external use only
When using this product
• avoid contact with the eyes.
Stop use and ask a doctor if
• condition worsens
• symptoms persist for more than 7 days or clear up and occur again
within a few days.
Keep out of reach of children. If swallowed, get medical help or contact a
Poison Control Center right away.
Directions
• To open, squeeze cap tightly and turn pump counter-clockwise. • Adults and
children 2 years of age and older: Apply to affected area not more than 3 to 4
times daily. • Children under 2 years of age: Consult a doctor
Aloe Barbadensis Leaf Juice
Carbomer
Cetyl Alcohol
Chamomilla Recutita (Matricaria) Flower Extract
Ethylhexylglycerin
Glyceryl Stearate
Isopropyl Myristate
PEG-100 Stearate
PEG-8 Stearate
Petrolatum
Phenoxyethanol
Sodium Hydroxide
Stearic Acid
Water
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8 | Product name | 1 | 20140508 |
| a7051cba-790b-a699-81f8-dbbbdbd9b5ac | Product name | 1 | 20140508 |
| da108d9e-edc8-17a3-8c28-3251c6a8accc | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11822-1236-6 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0249-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11822-1236-6 | First Aid Sensitive Anti-Itch | 222 mL in 1 BOTTLE | LOTION | 222 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11822-1236 | FIRST AID SENSITIVE ANTI-ITCH (PRAMOXINE HYDROCHLORIDE 1.0%) LOTION [RITE AID] | 1 | Legacy NDC, 1 package rows | 20180620_989201ae-e09b-4f15-9a44-d48b09933150.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 11822-1236 | 11822-1236-6 |
Every source-derived ingredient row is available through these pages.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 59ad278a-af21-4049-874a-624751fed57a | 989201ae-e09b-4f15-9a44-d48b09933150 | 2018-06-19 | Warnings | 59ad278a-af21-4049-874a-624751fed57a 989201ae-e09b-4f15-9a44-d48b09933150 |
Adverse event summaries are temporarily unavailable. Other product information remains available.