ACTIVE INGREDIENTS
| Active Ingredients | Purpose |
|---|---|
| Methyl Salicylate 10% | Topical Analgesic |
| Menthol 10% | Topical Analgesic |
| Camphor 3.1% | Topical Analgesic |
GADADERM Frozen Ice Advance Pain Relief
- Manufacturer
- GADAL Laboratories, Inc
- Effective date
- 2016-11-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 22:48:02
Label at a glance#
ProductGADADERM Frozen Ice Advance Pain Relief
Active ingredientMETHYL SALICYLATE, MENTHOL, CAMPHOR (NATURAL)
Label structure6 sections
Label contents#
Full prescribing information#
INACTIVE INGREDIENT
Carbopol, Cetearyl Alcohol, Disodium EDTA, FD&C Blue #1, Glycerin, Hydroxypropyl Methylcellulose, Menthylparaben, Propylene Glycol, Propylparaben, Polysorbate 20, Purified Water, Stearic Acid, Sodium Hydroxide.
WARNINGS
For the external use only. When using this product use as directed.
- Do not bandage tightly or use with heating pad. Avoid contact with eyes and mucous membranes.
- Do not apply to wounds or damaged, broken, or irritated skin.
- If severe burning sensation occurs, discontinue use immediately.
- Do not expose the area treated with product to heat or direct sunlight.
- Stop use and ask a doctor if conditions worsen, redness is present, irritation develops.
If swallowed, get medical help or contact a Poison Control Center right away. IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.
DOSAGE & ADMINISTRATION
Adults and children 12 years of age and older; apply generously to affected area massage into painful area until thoroughly absorbed into skin. Repeat as necessary but not more than 3 to 4 times daily.
PURPOSE
For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains.
GADADERM Frozen Ice Advance Pain Relief
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1438765 | camphor 3.1 % / menthol 10 % / methyl salicylate 10 % Topical Gel | PSN | 2 |
| 1438765 | camphor 0.031 MG/MG / menthol 0.1 MG/MG / methyl salicylate 0.1 MG/MG Topical Gel | SCD | 2 |
| 1438765 | camphor 3.1 % / methyl salicylate 10 % / menthol 10 % Topical Gel | SY | 2 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53113-362-09 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-34bd-f424-e053-dadaa90a57ce | 7bf21905-975a-472d-a2d6-a9c1408e7f95 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53113-362-09 | GADADERM Frozen Ice Advance Pain Relief | 99 g in 1 TUBE | GEL | 99 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- GADADERM Frozen Ice Advance Pain Relief
- SALICYLIC ACID MENTHOL CAMPHOR (NATURAL)
- METHYL SALICYLATE
- SALICYLIC ACID
- MENTHOL
- CAMPHOR (NATURAL)
- CARBOXYPOLYMETHYLENE
- PROPYLENE GLYCOL
- CETOSTEARYL ALCOHOL
- EDETATE DISODIUM ANHYDROUS
- FD&C BLUE NO. 1
- GLYCERIN
- HYPROMELLOSE, UNSPECIFIED
- METHYLPARABEN
- PROPYLPARABEN
- POLYSORBATE 20
- WATER
- STEARIC ACID
- SODIUM HYDROXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53113-362 | 53113-362-09 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| METHYL SALICYLATE | LAV5U5022Y | ACTIB |
| MENTHOL | L7T10EIP3A | ACTIB |
| CAMPHOR (NATURAL) | N20HL7Q941 | ACTIB |
| CARBOXYPOLYMETHYLENE | 0A5MM307FC | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| EDETATE DISODIUM ANHYDROUS | 8NLQ36F6MM | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| POLYSORBATE 20 | 7T1F30V5YH | IACT |
| WATER | 059QF0KO0R | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | 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 |
|---|---|---|---|---|---|---|
| f65d52ae-8348-4691-b432-7ca05fad5fd3 | 7bf21905-975a-472d-a2d6-a9c1408e7f95 | 2016-11-18 | Warnings | f65d52ae-8348-4691-b432-7ca05fad5fd3 7bf21905-975a-472d-a2d6-a9c1408e7f95 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.