ARNEU- camphor menthol cream

Arneu by

Drug Labeling and Warnings

Arneu by is a Otc medication manufactured, distributed, or labeled by CC Medical Devices Inc, Gar Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Camphor 3.100%

Menthol 3.000%

PURPOSE

Purpose

Topical Analgesic

Topical Analgesic

INDICATIONS & USAGE

Uses

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

Penetrating pain relief.

WARNINGS

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.

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

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 INGREDIENT

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).

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

ARNEU 
camphor menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42046-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Camphor (Natural) (UNII: N20HL7Q941) (Camphor (Natural) - UNII:N20HL7Q941)	Camphor (Natural)	3.1 g  in 100 g
Menthol (UNII: L7T10EIP3A) (Alcohol - UNII:3K9958V90M)	Menthol	3.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42046-002-03	85 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/28/2010

Labeler - CC Medical Devices Inc (121825868)

Establishment
Name	Address	ID/FEI	Business Operations
Gar Laboratories		074933615	manufacture