Label: C9 CREAM- menthol cream cream
- NDC Code(s): 82556-2009-1, 82556-2009-2
- Packager: OceanSide Health Products Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 23, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingridients
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Inactive Ingredients
Water, Scoth Pine Essential Oil, Clove Bud Oil, Melaleuca Cajeput Oil, Eucalyptus essential oil, Abies Sberica Oil, Arnica Montana flower extract, Turmeric,ethanol, 1,3 Propanediol, sorbic acid, phenoxyethanol, citric acid, Ammonium Acryloyldimethyltaurate/VP copolymer,t-Butyl alcohol,denatonium benzoate.
- INDICATIONS
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Instruction for use
DOSAGE/USAGE INSTRUCTIONS - Topical, (children over 2 years old, adolescents and adults): Application should be supervised by an adult (for children and adolescents from 2-12 years old). Apply thinly and evenly to the affected area up to 5 times per day. Rub and/or massage into skin until solution vanishes. For external use only. Avoid contact with the eyes and mucous membranes. Do not apply to wounds or damaged skin. Do not tensely/tightly bandage. Do not apply with external heat, such as an electric heating pad, as this may result in excessive skin irritation or skin burn. Consult a healthcare practitioner/health care provider/health care professional/doctor/ physician for use beyond 7 days.
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BOXED WARNING
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Boxed Warning
Keep out of the reach of children. Call a Poison Control Center immediately if overdose or accidental ingestion occurs. Stop use and consult a healthcare practitioner/health care provider/health care professional/ doctor/physician if symptoms worsen, or reoccur within a few days. Consult a healthcare practitioner/health care provider/health care professional/ doctor/physician prior to use if you are pregnant or breastfeeding.
- pregnancy and breastfeeding
- stop use
- Dosage and adminstration
- warning section
- keep out of reach of childern
- OTC PURPOSE Section
- PRINCIPAL DISPLAY PANEL -
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INGREDIENTS AND APPEARANCE
C9 CREAM
menthol cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82556-2009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 55 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) 0.01 mL in 1 mL SORBIC ACID (UNII: X045WJ989B) 0.002 mL in 1 mL SCOTCH SPEARMINT OIL (UNII: I5T0098W81) 0.0025 mL in 1 mL EUCALYPTUS OIL (UNII: 2R04ONI662) 0.00125 mL in 1 mL CLOVE OIL (UNII: 578389D6D0) 0.00125 mL in 1 mL TURMERIC (UNII: 856YO1Z64F) 0.0003 mL in 1 mL 1,3-PROPANEDIOL BIS(4-AMINOBENZOATE) (UNII: 8860R9ORQR) 0.02 mL in 1 mL ABIES SIBIRICA LEAF OIL (UNII: XRY0V4VZKZ) 0.00125 mL in 1 mL ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR) 0.0001 mL in 1 mL WATER (UNII: 059QF0KO0R) 0.843 mL in 1 mL MELALEUCA CAJUPUTI LEAF OIL (UNII: 5O59RMR6DU) 0.00125 mL in 1 mL AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) 0.06 mL in 1 mL TERT-BUTYL ALCOHOL (UNII: MD83SFE959) 0.00012 mL in 1 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.01 mL in 1 mL DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) 0.0000001 mL in 1 mL ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.001 mL in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82556-2009-1 200 mL in 1 TUBE; Type 0: Not a Combination Product 03/01/2023 2 NDC:82556-2009-2 50 mL in 1 TUBE; Type 0: Not a Combination Product 03/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/01/2023 Labeler - OceanSide Health Products Ltd (204406417)
