C9 Cream by OceanSide Health Products Ltd

Drug Details [pdf]

C9 CREAM- menthol cream cream
OceanSide Health Products Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active Ingridients

L- Menthol .......... 5.5%

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

INDICATIONS: Temporarily relieves aches and pains of muscles and joints associated with one or more of the following: simple backache, lumbago, strains and sprains (involving muscles, tendons, and/or ligaments), and arthritis.

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.

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

Consult a healthcare practitioner/health care provider/health care professional/ doctor/physician prior to use if you are pregnant or breastfeeding.

stop use

KNOWN UNDESIRABLE REACTIONS : STOP USE if hypersensitivity/allergy, rashes and/or burning discomfort occur. Stop use and get medical help right away if you experience pain, swelling or blistering.

Dosage and adminstration

Refer Image dosage and administration

warning section

refer image warning secion

keep out of reach of childern

refer image keep out of reach of children

OTC PURPOSE Section

Refer the top most content on the english sie. Purpose Indication

PRINCIPAL DISPLAY PANEL -

front panel NPN 80117178

NDC

C9 cream

Cryophyll #9

Naturally relaxing Menthol with

Arnica &Turmeric

Deep and sustained alleviation from Musculo-Skeletal Sore/Stifness Arthritic Pain Pulled or Aching Tendons

200ml

Cream/Creme

C9 CREAM
menthol cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82556-2009
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	55 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		03/01/2023	03/01/2023

Labeler - OceanSide Health Products Ltd (204406417)

Revised: 7/2024

Document Id: 1d4d7cae-b6c9-fd8d-e063-6394a90a528b

Set id: f2f77015-be33-8349-e053-2a95a90ab8d9

Version: 2

Effective Time: 20240715