Dosage and administration
ADULTS AND CHILDREN OVER 12 YEARS: APPLY TO AFFECTED AREA AND GENTLY MASSAGE OVER AREA UNTIL ABSORBED. DO NOT USE MORE THAN 4 TIMES A DAY. WASH HANDS AFTER GEL IS APPLIED.
ULTRACIN M
- Manufacturer
- Cal Pharma
- Effective date
- 2016-01-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:29:21
Label at a glance#
ProductULTRACIN M
Active ingredientMENTHOL
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
MENTHOL (5%)
OTC - PURPOSE SECTION
TOPICAL ANALGESIC
INDICATIONS & USAGE SECTION
USE
- TEMPORARILY RELIEVES MILD ACHES, PAINS AND INFLAMMATION OF MUSCLE AND JOINTS ASSOCIATED WITH NERVE DAMAGE AND SPORT INJURIES.
WARNINGS SECTION
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE ON OPEN WOUNDS, CUTS, DAMAGED OR INFECTED SKIN AS WELL AS IN THE EYES, MOUTH, GENITALS OR OTHER MUCOUS MEMBRANE
STOP USE AND CONSULT YOUR PHYSICIAN IF PAIN IS PERSISTENT OR WORSENS
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
OTC - PREGNANCY OR BREAST FEEDING SECTION
IF PREGNNT OR BREAST-FEEDING, ASK A HEALTHCARE PROFESSIONAL BEFORE USE.
DIRECTIONS
ADULTS AND CHILDREN OVER 12 YEARS: APPLY TO AFFECTED AREA AND GENTLY MASSAGE OVER AREA UNTIL ABSORBED. DO NOT USE MORE THAN 4 TIMES A DAY. WASH HANDS AFTER GEL IS APPLIED.
INACTIVE INGREDIENTS
Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Arnica Montana (Arnica) Flower Extract, Benzyl Alcohol, Boswelia Serrata Extract, Citrus Limon, Denatured Dehydrated Alcohol 40B, Gaultheria Procumbens (Wintergreen) Leaf Oil Extract, Petasites Japonicus Root (Butterbur) Extract,Pine (Pinetree) Bark Extract, Salix Nigra (Willow) Bark Extract, Zanthoxylum Americanum (Prickly Ash) Bark Extract Zanthoxylum Bungeanum Fruit (Sichuan Peppercorn) Extract, Water
OTC - QUESTIONS SECTION
QUESTIONS OR COMMENTS? 1-888-551-7778
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55628-9107-4 | 2024-04-01 | C162847 | 48780-1 | d6a99b39-9c04-a426-e053-dadaa90af4c2 | 06f84b11-579b-4c9c-a5ad-e3f3a59b98c7 |
| 55628-9107-4 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9c04-a426-e053-dadaa90af4c2 | 06f84b11-579b-4c9c-a5ad-e3f3a59b98c7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55628-9107-4 | ML - Milliliter | 55628-9107 | 37f6bf04-90e7-48e5-88e3-a7ff2bafc048 | 1 | 2016-02-04 |
Products#
Every source-derived product name is available through these pages.
- ULTRACIN M
- MENTHOL
- AMINOMETHYLPROPANOL
- ALOE VERA LEAF
- CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
- ARNICA MONTANA FLOWER WATER
- BENZYL ALCOHOL
- BOSWELLIA SERRATA WHOLE
- CITRUS LIMON WHOLE
- ALCOHOL
- GAULTHERIA PROCUMBENS LEAF
- PETASITES JAPONICUS ROOT
- MARITIME PINE
- WILLOW BARK
- ZANTHOXYLUM AMERICANUM BARK
- ZANTHOXYLUM BUNGEANUM FRUIT
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55628-9107 | 55628-9107-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| 150deca5-3573-4f90-e063-6394a90abc34 | 06f84b11-579b-4c9c-a5ad-e3f3a59b98c7 | 2024-04-01 | Warnings | 06f84b11-579b-4c9c-a5ad-e3f3a59b98c7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.