Storage and handling
Other information store at room temperature, not to exceed 86°F (30°C)
Other information store at room temperature, not to exceed 86°F (30°C)
Active ingredient Purpose
Menthol 5%..........................................................................Topical analgesic
Uses
Temporarily relieves minor pain associated with:
Warnings
For external use only
W hen using this product
Stop use and ask a doctor if
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.
Directions
children 12 years or younger:
Other information
Inactive ingredients 1,3-butlene glycol, aloe vera, BHT, d-sorbitol, disodium edetate, gelatin, glycerin, kaolin, liquid paraffin, magnesium aluminum hydrate, methacrylic acid butylacrylate copolymer, methyl parahydroxybenzoate, polysorbate 80, purified water, sodium metaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, tocopherol acetate
Distributed By:
Major Pharmaceuticals
17177 N Laurel Park Dr.
Suite 233
Livonia, MI 48150
Made in Korea
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0904-5694-01 | 2024-11-07 | C162847 | 48780-1 | d6a99b39-68ce-a426-e053-dadaa90af4c2 | Major Cold & Hot patch, 5ct in resealable pouch (69401) |
| 0904-5694-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-68ce-a426-e053-dadaa90af4c2 | Major Cold & Hot patch, 5ct in resealable pouch (69401) |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-5694-01 | EA - Each | 0904-5694 | c4646f21-4e64-4ac4-aad1-c37b877d931b | 1 | 2013-08-02 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | 1 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 1 | |
| ALPHA-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| KAOLIN | INACTIVE INGREDIENT | 24H4NWX5CO | 1 | |
| LIGHT MINERAL OIL | INACTIVE INGREDIENT | N6K5787QVP | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 1 | |
| SODIUM POLYMETAPHOSPHATE | INACTIVE INGREDIENT | P1BM4ZH95L | 1 | |
| SORBITAN MONOOLEATE | INACTIVE INGREDIENT | 06XEA2VD56 | 1 | |
| TARTARIC ACID | INACTIVE INGREDIENT | W4888I119H | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0904-5694 | 0904-5694-01 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| TARTARIC ACID | TARTARIC ACID | W4888I119H | TABLET, COATED / ORAL | 10 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CREAM / TOPICAL | 80 mg | ||
| TARTARIC ACID | TARTARIC ACID | W4888I119H | PELLET / ORAL | 354 mg | ||
| ALPHA-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | FILM / BUCCAL | 0.09 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | CREAM / TOPICAL | 456 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, ORALLY DISINTEGRATING / SUBLINGUAL | 13 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INFILTRATION | 6 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GEL / TOPICAL | 24 mg | ||
| TARTARIC ACID | TARTARIC ACID | W4888I119H | SOLUTION / ORAL | 270 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | AEROSOL, FOAM / VAGINAL | 3 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / SOFT TISSUE | 4 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, CHEWABLE / ORAL | 1.28 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / INTRA-ARTICULAR | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERIDURAL | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SYSTEM / TOPICAL | 126 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, SUGAR COATED / ORAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | AEROSOL, FOAM / TOPICAL | 0.05 %w/w | ||
| KAOLIN | KAOLIN | 24H4NWX5CO | CAPSULE, COATED PELLETS / ORAL | 234 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM / BUCCAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / TOPICAL | 3000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| KAOLIN | KAOLIN | 24H4NWX5CO | TABLET, DELAYED RELEASE / ORAL | 18.5 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SYSTEM / TOPICAL | 1050 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / EPIDURAL | 30 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| TARTARIC ACID | TARTARIC ACID | W4888I119H | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 20 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, CHEWABLE / ORAL | 24 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY / VAGINAL | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRAMUSCULAR | 4 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, EXTENDED RELEASE / ORAL | 0.17 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | EMULSION / TOPICAL | 0.11 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 4 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 42 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 14 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | CAPSULE / ORAL | 6 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / AURICULAR (OTIC) | 0.01 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SPRAY / TOPICAL | 0.2 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, FILM COATED / ORAL | 4 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| GELATIN | GELATIN | 2G86QN327L | DROPS / NASAL | 50 mg/1ml | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | TABLET, DELAYED RELEASE / ORAL | 4 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRALESIONAL | 0.05 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / TRANSDERMAL | 1 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED PELLETS / ORAL | 4.4 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SYRUP / ORAL | 40 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, DELAYED RELEASE / ORAL | 23 mg |
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 |
|---|---|---|---|---|---|---|
| 82a6a41c-3246-4258-a280-1f046ae614cb | 33e3bc1d-3eb7-4f04-9002-6a384c91fc3d | 2024-11-06 | Warnings | 33e3bc1d-3eb7-4f04-9002-6a384c91fc3d |
Adverse event summaries are temporarily unavailable. Other product information remains available.