Websitewww.gadallaboratories.com
www.gadallaboratories.com
www.gadallaboratories.comFROZEN ICE FAST PAIN RELIEF
- Manufacturer
- GADAL Laboratories, Inc
- Effective date
- 2016-11-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 22:48:23
Label at a glance#
ProductFROZEN ICE FAST PAIN RELIEF
Active ingredientMENTHOL, CAMPHOR (NATURAL)
Label structure9 sections
Contacts and useful links#
Label contents#
Full prescribing information#
ACTIVE INGREDIENT
| Active Ingredients | Purpose |
|---|---|
| Menthol 3.5% | Topical Analgesic |
| Camphor 0.2% | Topical Analgesic |
INACTIVE INGREDIENT
Carbomer, Propylene Glycol, Methylparaben, Isopropyl Alcohol, Triethanolamine, FD&C Blue #1, Purified Water.
KEEP OUT OF REACH OF CHILDREN
KEEP THIS AND ALL MEDICINE OUT OF REACH OF CHILDREN
WARNINGS
For the external use only. Use only as directed.
- If condition worsens, or if symptoms persist for more than 7 days or clear up and occurs again within a few days, discontinue use of this product and consults a doctor.
- Avoid contact with eyes.
- Do not use with other topical products.
- Do not use with heating device.
- Do not apply to open wounds or damaged skin.
In case of accidental ingestion, seek professional help and contact a Poison Control Center immediately.
INDICATIONS & USAGE SECTION
For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains.
DOSAGE & ADMINISTRATION
Adults and children 12 years of age and older.
Apply to painful muscles and joints.
Gently massage thoroughly into affected area.
Repeat as necessary but no more than 4 times daily
PURPOSE
Topical Analgesic
Other Information:
Store in cool, dry location at room temperature 59°- 86°F (15° - 30°C) with cao closed tightly. Keep away from excessive heat or open flame.
Manufactured by:
GABAL Laboratories, Inc.
Miami, FL 33186 – (305)382-3288
MADE IN USA
FROZEN ICE FAST PAIN RELIEF
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53113-363-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-9ce5-f424-e053-dadaa90a57ce | Gadaderm Frocen Ice FastmPain Releive |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53113-363-03 | FROZEN ICE FAST PAIN RELIEF | 89 mL in 1 APPLICATOR | GEL | 89 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- FROZEN ICE FAST PAIN RELIEF
- MENTHOL CAMPHOR (NATURAL)
- MENTHOL
- CAMPHOR (NATURAL)
- CARBOXYPOLYMETHYLENE
- PROPYLENE GLYCOL
- METHYLPARABEN
- ISOPROPYL ALCOHOL
- TROLAMINE
- FD&C BLUE NO. 1
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53113-363 | 53113-363-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MENTHOL | L7T10EIP3A | ACTIB |
| CAMPHOR (NATURAL) | N20HL7Q941 | ACTIB |
| CARBOXYPOLYMETHYLENE | 0A5MM307FC | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| WATER | 059QF0KO0R | IACT |
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 |
|---|---|---|---|---|---|---|
| e06290e3-85ad-4729-96b0-6f063c656081 | 636cb454-eef9-4509-96cd-7deeb2abd0ac | 2016-11-24 | Warnings | e06290e3-85ad-4729-96b0-6f063c656081 636cb454-eef9-4509-96cd-7deeb2abd0ac |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.