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ULTRACIN M by Cal Pharma

Medically reviewed on January 24, 2018

Dosage form: gel
Ingredients: MENTHOL 5g in 100mL
Labeler: Cal Pharma
NDC Code: 55628-9107

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

MENTHOL (5%)

TOPICAL ANALGESIC

USE

- TEMPORARILY RELIEVES MILD ACHES, PAINS AND INFLAMMATION OF MUSCLE AND JOINTS ASSOCIATED WITH NERVE DAMAGE AND SPORT INJURIES.

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

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

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

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ULTRACIN M 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55628-9107
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage Description
1NDC:55628-9107-4120 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/24/2016
Labeler - Cal Pharma (078721283)
Registrant - Cal Pharma (078721283)

 
Cal Pharma

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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