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
When using this product
Stop use and ask a doctor if
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
If pregnant or breast-feeding, ask a health professional before use.
Directions
Other information
Inactive ingredients 1,3-butylene glycol, aloe vera (powder), metacrylic acid butylacrylic acid butylacrylate copolymer, dibutylhydroxytoluene, disodium edetate, D-sorbitol solution, gelatin, glycerine, kaolin, light liquid paraffin, magnesium aluminium hydrate, methyl parahydroxybenzoate, polysorbate 80, purified water, sodium metaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium oxide, tocopherol acetate.
Distributed By:
Rite Aid
30 Hunter Lane
Camp Hill, PA 17011
Made in Korea
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11822-5649-5 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1a8e-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11822-5649-5 | Rite Aid Extra Strength Pain Relief Cold and Hot Medicated | 5 in 1 POUCH | PATCH | 5 | 1 | |
| 11822-5649-5 | Rite Aid Extra Strength Pain Relief Cold and Hot Medicated | 1 in 1 CARTON | PATCH | 1 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11822-5649 | RITE AID EXTRA STRENGTH PAIN RELIEF COLD AND HOT MEDICATED (MENTHOL) PATCH [RITE AID] | 1 | Legacy NDC, 2 package rows | 20130717_e091cbe1-ffd2-43ac-84a8-14103eb8ca50.zip |
| 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 |
|---|---|
| 11822-5649 | 11822-5649-5 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MENTHOL | L7T10EIP3A | ACTIB |
| BUTYLENE GLYCOL | 3XUS85K0RA | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| KAOLIN | 24H4NWX5CO | IACT |
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM POLYMETAPHOSPHATE | P1BM4ZH95L | IACT |
| SORBITAN MONOOLEATE | 06XEA2VD56 | IACT |
| TARTARIC ACID | W4888I119H | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ALPHA-TOCOPHEROL ACETATE | 9E8X80D2L0 | IACT |
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 |
|---|---|---|---|---|---|---|
| TARTARIC ACID | TARTARIC ACID | W4888I119H | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 20 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE / ORAL | 55 mg | ||
| GELATIN | GELATIN | 2G86QN327L | POWDER, FOR SUSPENSION / ORAL | NA | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | GEL / TOPICAL | 20 mg | ||
| SODIUM POLYMETAPHOSPHATE | SODIUM POLYMETAPHOSPHATE | P1BM4ZH95L | SOLUTION / BUCCAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, COATED / ORAL | 42.12 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 14 mg | ||
| ALPHA-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | FILM / BUCCAL | 0.09 mg | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | SPRAY / TOPICAL | 8 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 14 mg | ||
| TARTARIC ACID | TARTARIC ACID | W4888I119H | INJECTION, SOLUTION / SUBCUTANEOUS | 18 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / AURICULAR (OTIC) | 0.01 %w/v | ||
| KAOLIN | KAOLIN | 24H4NWX5CO | SYSTEM / TOPICAL | 420 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / OPHTHALMIC | 1 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | SYSTEM / TRANSDERMAL | 2.33 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET / ORAL | 233 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRAMUSCULAR | 4 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SUBCUTANEOUS | 22 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / AURICULAR (OTIC) | NA | ||
| TARTARIC ACID | TARTARIC ACID | W4888I119H | INJECTION, SOLUTION / INTRAVENOUS | 20 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRA-ARTICULAR | 4 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | ELIXIR / ORAL | 800 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CAPSULE / ORAL | 7 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SOLUTION / ORAL | 126 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | EMULSION / TOPICAL | 34050 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM / BUCCAL | 3 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / OPHTHALMIC | 4 mg | ||
| TARTARIC ACID | TARTARIC ACID | W4888I119H | INJECTION / INTRAVENOUS | 20 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / VAGINAL | 5 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR | 5 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION / AURICULAR (OTIC) | 0.2 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAVENOUS | 45 mg | ||
| KAOLIN | KAOLIN | 24H4NWX5CO | TABLET, EXTENDED RELEASE / ORAL | 66 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 3.6 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUPPOSITORY / RECTAL | 72.15 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERINEURAL | 80 mg | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | SOLUTION / ORAL | 1080 mg | ||
| KAOLIN | KAOLIN | 24H4NWX5CO | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 234 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SHAMPOO, SUSPENSION / TOPICAL | 1 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, FILM COATED / ORAL | 24 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRA-ARTICULAR | 0.05 %w/v | ||
| GELATIN | GELATIN | 2G86QN327L | SOLUTION / ORAL | 34.8 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | GRANULE, FOR SUSPENSION / ORAL | 240 mg | ||
| TARTARIC ACID | TARTARIC ACID | W4888I119H | SYSTEM / TOPICAL | 349 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / AURICULAR (OTIC) | 0.1 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | POWDER, FOR SUSPENSION / ORAL | 285 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION / INTRAVENOUS | 20 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / TOPICAL | 0.16 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 6 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IRRIGATION | 2 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LOTION / TOPICAL | 351 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, EXTENDED RELEASE / ORAL | 0.17 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / TOPICAL | 0.24 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | PASTE, DENTIFRICE / DENTAL | 0.05 %w/w |
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 |
|---|---|---|---|---|---|---|
| 2e636405-0db7-4985-8774-eef63369667e | e091cbe1-ffd2-43ac-84a8-14103eb8ca50 | 2013-06-30 | Warnings | 2e636405-0db7-4985-8774-eef63369667e e091cbe1-ffd2-43ac-84a8-14103eb8ca50 |
Adverse event summaries are temporarily unavailable. Other product information remains available.