ULTRACIN M- menthol gel 
Cal Pharma

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Cal Pharma (as PLD) - ULTRACIN M (55628-9107) - DELIST

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 copy

ULTRACIN M 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55628-9107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)  
CITRUS LIMON WHOLE (UNII: EEI224A33Y)  
ALCOHOL (UNII: 3K9958V90M)  
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
PETASITES JAPONICUS ROOT (UNII: 6F650HF10T)  
MARITIME PINE (UNII: 50JZ5Z98QY)  
WILLOW BARK (UNII: S883J9JDYX)  
ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T)  
ZANTHOXYLUM BUNGEANUM FRUIT (UNII: 3CIP16A418)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55628-9107-4120 mL in 1 TUBE; Type 0: Not a Combination Product01/24/201612/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/24/201612/31/2023
Labeler - Cal Pharma (078721283)

Revised: 4/2024
 
Cal Pharma