RHULIEF PAIN RELIEVING BALM (menthol, camphor- synthetic cream

Rhulief Pain Relieving Balm by

Drug Labeling and Warnings

Rhulief Pain Relieving Balm by is a Otc medication manufactured, distributed, or labeled by EuroPharma, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol 1.30%

Camphor 3.50%

Purpose

Topical Analgesic

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings

• For esternal use only.
• Avoid contact with the eyes.
• Do not bandage tightly or use hearing pad.
• Do not apply to open wounds or damaged skin.

Discontinue use of this product and consult a physician if condition worsens, symptoms perist for more than 7 days or clear up and occur again within a few days, or excessive skin irritation occurs.

Discontinue use of this product and consult a physician

if condition worsens, symptons persist for more than 7 days, or excessive skin irrirtation occurs.

Keep our of the reach of children.

If swallowed, get medical help or contct a Poison control Center immediately.

Directions:

Adults and children 12 years of age and older:

Apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age: Consult a physician.

Inactive Ingredients:

Beeswax, Boswellia(Boswellia Serrata) Gum Resin Extract, Coconut (Cocos Nucifera) Fuit Oil, Eucalyptus (Eucalyptus Globulus) Leaf Extract, Sesame (Sesamum Indicum) Seed Oil.

Package Label:

INGREDIENTS AND APPEARANCE

RHULIEF PAIN RELIEVING BALM 
menthol, camphor (synthetic) cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67703-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.3 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	3.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)
COCONUT OIL (UNII: Q9L0O73W7L)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
SESAME SEED (UNII: 7Y1255HVXR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67703-002-00	1 in 1 PACKAGE	01/26/2017	10/31/2020
1		40 g in 1 BOX; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/26/2017	10/31/2020

Labeler - EuroPharma, Inc (060446577)

Registrant - EuroPharma, Inc (060446577)