ARNEU - camphor menthol cream 
CC Medical Devices Inc

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.

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Drug Facts

Active Ingredients

Camphor 3.100%

Menthol 3.000%

Purpose

Topical Analgesic

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints.

Penetrating pain relief.

Warnings

For external use only.

Do not bandage tightly.

Do not apply heat to the area of application.

Do not apply to open wounds or damaged skin.

Avoid contact with eyes or mucous membranes.

Ask a doctor before use, if you have ever experienced a reaction due to ingredients listed.

Stop use and consult a licensed health professional if conditions worsens or if symptoms persists for more than 7 days, or clears up and occurs again.

If pregnant or breast feeding, ask the health professional before use.

Keep out of reach of children.

If ingestion occurs, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age or older

Apply to surface, leaving a thin visible film; by applying a thicker film, the intensity is increased.

Apply to the area of pain, extending outside of the area slightly.

Apply 2 times a day minimum (do not exceed application of 4 times daily).

Allow to dry completely before applying loose clothing over the area.

Directions

(Children 12 years of age or younger)

Ask your doctor or a licensed health professional.

Other Information

Store at 15-30 C (50-85 F). Keep sealed tightly.

No triethanolamine used in manufacturing.

Have all medical diagnosis confirmed by a healthcare professional before treating.

Do not use if cap seal has been tampered with.

Inactive Ingredients

Water, propylene glycol, glycerin, witch hazel, carbomer, sodium hydroxymethylglycinate, fragrance, arnica montana flower extract, potassium asparate, sodium chlorite, willow bark extract, green tea leaf extract, sodium hydroxide, spirulina maxima extract, aloe vera leaf juice, ginger root extract, bromelain, boswellia serrata gum, sodium sesquicarbonate, sodium bicarbonate, capsaicin (capsicum frutescens fruit extract).

ArNeu

penetrating pain relief

God Formula

Topical Analgesic Counterirritant

For the Temporary Relief of Minor Aches and Pains of Muscles and Joints

NET WT. 3.0 OZ. (85 g.)

www.arneu.com

NDC 42046-002-03

US Pat.7,704,522 and Pat. Pending

Made in USA

container label


ARNEU 
camphor menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42046-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Camphor (Natural) (UNII: N20HL7Q941) (Camphor (Natural) - UNII:N20HL7Q941) Camphor (Natural)3.1 g  in 100 g
Menthol (UNII: L7T10EIP3A) (Alcohol - UNII:3K9958V90M) Menthol3.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Glycerin (UNII: PDC6A3C0OX)  
Witch Hazel (UNII: 101I4J0U34)  
Arnica Montana Flower (UNII: OZ0E5Y15PZ)  
Potassium Aspartate (UNII: OC4598NZEQ)  
Sodium Chlorite (UNII: G538EBV4VF)  
Willow Bark (UNII: S883J9JDYX)  
Green Tea Leaf (UNII: W2ZU1RY8B0)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Ginger (UNII: C5529G5JPQ)  
Bromelains (UNII: U182GP2CF3)  
Sodium Bicarbonate (UNII: 8MDF5V39QO)  
Capsaicin (UNII: S07O44R1ZM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42046-002-0385 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/28/2010
Labeler - CC Medical Devices Inc (121825868)
Establishment
NameAddressID/FEIBusiness Operations
Gar Laboratories074933615manufacture

Revised: 8/2010
Document Id: 3a805223-101e-4b49-9a6f-a77b127d5d51
Set id: b831463d-1c7d-44e1-9b8c-f03d31e15829
Version: 1
Effective Time: 20100828
 
CC Medical Devices Inc