Indications and uses
for the temporary relief of pain and itching due to: minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations ,minor rashes due to poison ivy, poison oak, or poison sumac
Fred's Medicated Anti itch Cream
- Manufacturer
- Fred's Inc. | Weeks and Leo, Inc. | Weeks & Leo, Inc.
- Effective date
- 2019-12-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:50:27
Label at a glance#
ProductFreds Medicated anti itch
Active ingredientPRAMOXINE HYDROCHLORIDE, MENTHOL
Label structure9 sections
Dosage and administration
adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily children under 2 years: consult a doctor
Storage and handling
store at controlled room temperature
Label contents#
Full prescribing information#
Active Ingredient
Menthol 1%
Pramoxine hydrochloride 1%
Uses
for the temporary relief of pain and itching due to: minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations ,minor rashes due to poison ivy, poison oak, or poison sumac
Purpose
Topical anagesic
Warnings
When using this product
do not get into eyes
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away.
Other Information
store at controlled room temperature
Directions
adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily
children under 2 years: consult a doctor
DOSAGE & ADMINISTRATION SECTION
Adults and Children 2 years and older: Apply to affected are not more than 3 to 4 times daily.
Inactive Ingredients
aloe barbadensis (aloe vera) leaf juice, diazolidinyl urea, edetate disodium, eucalyptus oil, methylparaben, methyl salicylate, mineral oil, PPG-1 trideceth-6, propylene glycol, propylparaben, purified water, sodium acrylates copolymer, steareth-21, stearyl alcohol, tocopheryl acetate, trolamine, white petrolatum
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Topical Analgesic
With Aloe and Vitamine E
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55315-265-01 | 2022-01-21 | C162847 | 48780-1 | ba0f9c33-5d39-a910-e053-dadaa90a0b85 | Fred's Medicated Anti itch Cream |
| 55315-265-01 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5d39-a910-e053-dadaa90a0b85 | Fred's Medicated Anti itch Cream |
Products#
Every source-derived product name is available through these pages.
- Freds Medicated anti itch
- Pramoxine hydrochloride, menthol
- METHYLPARABEN
- DIAZOLIDINYL UREA
- PROPYLPARABEN
- WATER
- PETROLATUM
- STEARYL ALCOHOL
- EUCALYPTUS OIL
- PRAMOXINE HYDROCHLORIDE
- PRAMOXINE
- STEARETH-21
- .ALPHA.-TOCOPHEROL ACETATE, DL-
- SODIUM POLYACRYLATE (8000 MW)
- EDETATE DISODIUM
- EDETIC ACID
- TROLAMINE
- MENTHOL
- PROPYLENE GLYCOL
- METHYL SALICYLATE
- ALOE VERA LEAF
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55315-265 | 55315-265-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| d61c59fe-d015-1c62-e053-2a95a90a8c51 | 85b98646-de35-7831-e053-2991aa0a6082 | 2022-01-21 | Warnings | 85b98646-de35-7831-e053-2991aa0a6082 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.