Indications and uses
Temporarily relieves minor pain associated with: arthritis backache bodyaches muscle pains leg cramps bursitis
Cold and Hot Cream
- Manufacturer
- MAGVERZ INC
- Effective date
- 2013-07-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:36:13
Label at a glance#
ProductCold and Hot
Active ingredientMENTHOL
Label structure8 sections
Dosage and administration
Adults and children over 1 years:apply generously to affected areamassage into painful area until thoroughly absorbed into skinrepeat as necessary, but no more than 4 times daily. Children 12 years or younger: ask a doctor. Close cap tighlty after use.
Label contents#
Full prescribing information#
Acitves
Menthol 7.5%
Inactives
aloe barbadensis leaf juice, beeswax, benzyl alcohol, capsaicin, cetearyl alcohol, cetyl alcohol, cetyl esters, cetyl palmitate, citrus paradise (grapefruit) peel oil, di-PEG-2 soyamine IPDI, disodium LPDL, distearyldimonium chloride, eucalyptus globules leaf oil, glycerin, hydrogenated olive oil, jojoba esters, melaleuca alternifolia (tea tree) leaf oil, menthe viridis (spearmint) leaf oil, olea europaea (olive) fruit oil, olea europaea (olive) oil unsaponifiables, polysorbate 60, potassium hydroxide, propanediol, sorbitan olivate, sorbitan palmitate, steareth-2, steareth-21, stearyl alcohol, water
Uses
Temporarily relieves minor pain associated with:
arthritis
backache
bodyaches
muscle pains
leg cramps
bursitis
Indication
Temporarily relieves minor pain
Directions
Adults and children over 1 years:apply generously to affected areamassage into painful area until thoroughly absorbed into skinrepeat as necessary, but no more than 4 times daily.
Children 12 years or younger: ask a doctor.
Close cap tighlty after use.
Warnings
For External use only
When using this product
Use only as directed
Do not bandage tightly or with heating pad
Avoid contact with eyes and mucous membranes
Do not apply to wounds or damagged, broken or irritated skin
Do not expose the area treated with product to heat or direct sunlight.
Stop use and ask docotor if;
Condition Worsesns, Symptomps persist for mor than 7 days or clear up and occur again within a few days, Irritation developes.
If pregnant or breast feeding
Ask health professionals before use.
If sollowed get medical help or contact poison control center right away.
Keep Out of Reach of Childrens
Keep out of reach of childrens.
Productt Label
Product Label
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 59240-003-01 | 2019-11-27 | C162847 | 48780-1 | 9855d018-ddf9-cd31-e053-dbdaa90ab51a | Cold and Hot Cream |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59240-003-01 | Cold and Hot | 25 g in 1 TUBE | CREAM | 25 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | 1 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 1 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | 1 | |
| CAPSAICIN | INACTIVE INGREDIENT | S07O44R1ZM | 1 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| CETYL ESTERS WAX | INACTIVE INGREDIENT | D072FFP9GU | 1 | |
| CETYL PALMITATE | INACTIVE INGREDIENT | 5ZA2S6B08X | 1 | |
| CITRUS PARADISI FRUIT OIL | INACTIVE INGREDIENT | 6A7N43E0OJ | 1 | |
| DISTEARYLDIMONIUM CHLORIDE | INACTIVE INGREDIENT | OM9573ZX3X | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| EUCALYPTUS OIL | INACTIVE INGREDIENT | 2R04ONI662 | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| HYDROLYZED JOJOBA ESTERS (ACID FORM) | INACTIVE INGREDIENT | UDR641JW8W | 1 | |
| OLIVE OIL | INACTIVE INGREDIENT | 6UYK2W1W1E | 1 | |
| PEG-80 SORBITAN PALMITATE | INACTIVE INGREDIENT | 4NR71FN0IA | 1 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | 1 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | 1 | |
| PROPANEDIOL | INACTIVE INGREDIENT | 5965N8W85T | 1 | |
| SORBITAN OLIVATE | INACTIVE INGREDIENT | MDL271E3GR | 1 | |
| SPEARMINT | INACTIVE INGREDIENT | J7I2T6IV1N | 1 | |
| STEARETH-2 | INACTIVE INGREDIENT | V56DFE46J5 | 1 | |
| STEARETH-21 | INACTIVE INGREDIENT | 53J3F32P58 | 1 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | 1 |
Products#
Every source-derived product name is available through these pages.
- Cold and Hot
- Menthol
- ALOE VERA LEAF
- YELLOW WAX
- BENZYL ALCOHOL
- CAPSAICIN
- CETOSTEARYL ALCOHOL
- CETYL ALCOHOL
- CETYL ESTERS WAX
- CETYL PALMITATE
- CITRUS PARADISI FRUIT OIL
- EDETATE DISODIUM
- DISTEARYLDIMONIUM CHLORIDE
- EUCALYPTUS OIL
- GLYCERIN
- OLIVE OIL
- HYDROLYZED JOJOBA ESTERS (ACID FORM)
- SPEARMINT
- POLYSORBATE 60
- POTASSIUM HYDROXIDE
- PROPANEDIOL
- SORBITAN OLIVATE
- PEG-80 SORBITAN PALMITATE
- STEARETH-2
- STEARETH-21
- STEARYL ALCOHOL
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 59240-003 | 59240-003-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
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 |
|---|---|---|---|---|---|---|
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, DELAYED RELEASE / ORAL | 0.1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / OPHTHALMIC | 4 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / INTRAVENOUS | 0.05 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / RESPIRATORY (INHALATION) | 0.01 %w/v | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | SUSPENSION / TOPICAL | 2.01 %w/w | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / TOPICAL | 2.01 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | LOTION / TOPICAL | 22 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | CAPSULE, EXTENDED RELEASE / ORAL | 1.23 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | SUPPOSITORY / VAGINAL | 8.5 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / OPHTHALMIC | 0.5 %w/v | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRALESIONAL | 23 mg | ||
| POTASSIUM HYDROXIDE | POTASSIUM HYDROXIDE | WZH3C48M4T | CREAM / VAGINAL | 3 mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | AEROSOL, FOAM / TOPICAL | 30 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, EMULSION / INTRAMUSCULAR | 225 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, FILM COATED / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| STEARETH-21 | STEARETH-21 | 53J3F32P58 | CREAM / TOPICAL | 3 %w/w | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / VAGINAL | 0.75 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, ORALLY DISINTEGRATING / ORAL | 3 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | LOTION / TOPICAL | 1140 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / AURICULAR (OTIC) | 0.1 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / ORAL | 432 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | POWDER / ORAL | 0.11 mg | ||
| POTASSIUM HYDROXIDE | POTASSIUM HYDROXIDE | WZH3C48M4T | SOLUTION / ORAL | ADJ PH | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRAVENOUS | 1620 mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | LOTION / TOPICAL | 5 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | AEROSOL, FOAM / RECTAL | 2 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRACARDIAC | 2 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | CREAM / VAGINAL | 1 %w/w | ||
| SPEARMINT | SPEARMINT | J7I2T6IV1N | SOLUTION / ORAL | 0.04 ml/5ml | ||
| CETYL ESTERS WAX | CETYL ESTERS WAX | D072FFP9GU | SUPPOSITORY / VAGINAL | NA | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET / ORAL | 3.22 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CAPSULE / ORAL | 44 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | EMULSION / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / TOPICAL | 82 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | LOTION / TOPICAL | 1140 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRA-ARTICULAR | 1 %w/v | ||
| CETYL PALMITATE | CETYL PALMITATE | 5ZA2S6B08X | CREAM / VAGINAL | 165 mg | ||
| POTASSIUM HYDROXIDE | POTASSIUM HYDROXIDE | WZH3C48M4T | GEL / TOPICAL | 3 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / AURICULAR (OTIC) | 1 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | GEL / RECTAL | 124 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / SUBCONJUNCTIVAL | 252 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SOLUTION / INTRA-ARTICULAR | 23 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / NASAL | 0.1 mg/1ml | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SUSPENSION / ORAL | 100 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, EMULSION / INTRAVENOUS | 59 mg |
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 |
|---|---|---|---|---|---|---|
| 23f2cb9b-3189-4389-a0b0-bfeb7c2ce53a | df791fdb-5984-43b0-b04c-2625ee6e5c0c | 2013-07-16 | Warnings | 23f2cb9b-3189-4389-a0b0-bfeb7c2ce53a df791fdb-5984-43b0-b04c-2625ee6e5c0c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.