Label: KYMARO ROLL ON RELIEF- menthol and camphor (synthetic) cream
- NDC Code(s): 64058-541-13
- Packager: Concept Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- ACTIVE INGREDIENT
for the temporary relief of minor aches and pains of muscles and joints associated with
- simple backache
For external use only.
- Flammable: Keep from heat and flame. Use only as directed.
- do not apply to wounds or damaged skin
- do not bandage tightly
- do not use with heating pad, wrap, hot water bottle or any heating element.
When using this product do not get into eyes
- avoid contact with other mucous membranes
- if eye contact occurs, flush immediately with water
Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
Keep out of reach of children.
- If swallowed, get medical help or contact a Poison Control Center right away.
- for adults and children 18 years of age and older
- apply liberally to affected area up to 4 times daily, unless otherwise directed by a physician
- allow to fully absorb into skin
- if necessary, wash hands with soap and water after application
- if applying to hands, wait 30 minutes before washing
- avoid contact with eyes, mucous membranes, damaged or irritated skin
- insert contact lenses prior to application
- Inactive ingredients
Water (Aqua), Aloe Barbadensis Leaf Juice, SD Alcohol 40-B, Propylene Glycol, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Carbomer, Acrylates Coploymer, Corn Starch Modified, Linum Usitatissmum (Linseed) Seed Oil, Euterpe Oleracea Fruit Oil, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil,Methyl Diisopropyl Propionamide, Ethyl Methane Carboximide, Methyl Lactate, Lauryl Laurate, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch, Hydrolyzed Starch Octenylsuccinate, Phenoxyethanol, DMDM Hydantoin, Iodopropynyl ButylcarbamateClose
- PRINCIPAL DISPLAY PANEL - 85g Bottle Label
HEALTH & BEAUTY / SPA ESSENTIALS
PAIN RELIEVING CREAM
NET WT 3 OZ (85g)
- INGREDIENTS AND APPEARANCE
KYMARO ROLL ON RELIEF
menthol and camphor (synthetic) cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64058-541 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10.2 g in 85 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 5.1 g in 85 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PEPPERMINT OIL (UNII: AV092KU4JH) ALCOHOL (UNII: 3K9958V90M) STARCH, CORN (UNII: O8232NY3SJ) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) LINSEED OIL (UNII: 84XB4DV00W) ROSEMARY OIL (UNII: 8LGU7VM393) ACAI OIL (UNII: Z0W6766A2W) PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X) METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489) METHYL LACTATE, L- (UNII: 0379G9C44S) LAURYL LAURATE (UNII: GPW77G0937) DMDM HYDANTOIN (UNII: BYR0546TOW) PHENOXYETHANOL (UNII: HIE492ZZ3T) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64058-541-13 85 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 09/24/2012 Labeler - Concept Laboratories, Inc. (962282612) Establishment Name Address ID/FEI Business Operations Concept Laboratories, Inc. 962282612 MANUFACTURE(64058-541)