SPL UNCLASSIFIED SECTION
for topical use only
Homeopathic External Analgesic Medicine
1.05 oz (30g)
for topical use only
Homeopathic External Analgesic Medicine
1.05 oz (30g)
For temporary relief of pain of bruises, sprains, swelling of joints and muscles.
Apply thinly on the affected area 1-3 times daily.
If symptoms persist more than a few days, contact a licensed practitioner. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product.
Keep this and all other medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Protect fom light and heat.
Do not use this product if metal seal under the tube cap is missing or broken.
1g ointment contains: 0.1g Acidum L(+) - lacticum 1X.
lanolin alcohol, glycerylmonostearate, propylene glycol, polyglyceryl-3, cocoate magnesium sulfate, water.
Made in Germany
Distributed by:
SANUM USA Corp.
1465 Slater Road
Ferndale, WA 98248
Manufactured by:
Sanum-Kehlbeck GmbH & Co. KG
Hoya, Germany
Rev. 03/2010
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 60681-6301-1 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-cdef-621f-e053-dbdaa90a74ad | Pleo ® Sanuvis Ointment 1X |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60681-6301-1 | Pleo Sanuvis | 1 in 1 CARTON | OINTMENT | 1 | 1 | |
| 60681-6301-1 | Pleo Sanuvis | 30 g in 1 TUBE | OINTMENT | 30 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 60681-6301 | PLEO SANUVIS (LACTIC ACID, L-) OINTMENT [SANUM KEHLBECK GMBH & CO. KG] | 1 | Legacy NDC, 2 package rows | 20100702_3c8d0d4f-d94e-4bd7-adba-788378da6847.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| lactic acid, l- | ACTIVE INGREDIENT | F9S9FFU82N | 1 | |
| lactic acid, l- | ACTIVE MOIETY | F9S9FFU82N | 1 | |
| glyceryl monostearate | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| lanolin alcohols | INACTIVE INGREDIENT | 884C3FA9HE | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 60681-6301 | 60681-6301-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| lactic acid, l- | F9S9FFU82N | ACTIB |
| glyceryl monostearate | 230OU9XXE4 | IACT |
| lanolin alcohols | 884C3FA9HE | IACT |
| water | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| lanolin alcohols | LANOLIN ALCOHOLS | 884C3FA9HE | CREAM / TOPICAL | 6 %w/w | ||
| lanolin alcohols | LANOLIN ALCOHOLS | 884C3FA9HE | OINTMENT / TOPICAL | 452 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | LOTION / TOPICAL | 177 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 23 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CAPSULE / ORAL | 13.75 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET / SUBLINGUAL | 1.23 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, DELAYED RELEASE / ORAL | 6 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | GRANULE, FOR SUSPENSION / ORAL | 4 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | AEROSOL, FOAM / VAGINAL | 3 %w/w | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUSPENSION / OPHTHALMIC | 0.5 %w/v | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | OINTMENT / TOPICAL | 5 %w/w | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, CHEWABLE / ORAL | 1 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CAPSULE, EXTENDED RELEASE / ORAL | 32.4 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | LIQUID / TOPICAL | 1 %w/w | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET / ORAL | 33.34 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | EMULSION / ORAL | NA | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUPPOSITORY / RECTAL | 35 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CREAM / VAGINAL | 140 mg | ||
| lanolin alcohols | LANOLIN ALCOHOLS | 884C3FA9HE | OINTMENT / OPHTHALMIC | 10 %w/w | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | AEROSOL, FOAM / TOPICAL | 3.27 %w/w | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CAPSULE, DELAYED RELEASE / ORAL | 15 mg | ||
| lanolin alcohols | LANOLIN ALCOHOLS | 884C3FA9HE | LOTION / TOPICAL | 9360 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUSPENSION / AURICULAR (OTIC) | 0.5 %w/v | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CREAM / TOPICAL | 836 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, EXTENDED RELEASE / ORAL | 529 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 |
|---|---|---|---|---|---|---|
| 3d49e515-0833-4585-bcbd-e8382a0bb006 | 3c8d0d4f-d94e-4bd7-adba-788378da6847 | 2010-06-04 | Warnings | 3d49e515-0833-4585-bcbd-e8382a0bb006 3c8d0d4f-d94e-4bd7-adba-788378da6847 |
Adverse event summaries are temporarily unavailable. Other product information remains available.