Rhulief Pain Relieving Balm

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]

RHULIEF PAIN RELIEVING BALM- menthol, camphor (synthetic) cream 
EuroPharma, 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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Rhulief Pain Relieving Balm

Active Ingredient

Menthol 1.30%

Camphor 3.50%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, stains, 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, symptons persist for more than 7 days, or excessive skin irrirtation occurs.

Keep our of the reach of childre.

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.

Rhulief Pain Relieving Balm, 40g (67703-001-00)

package label

bottle label

RHULIEF PAIN RELIEVING BALM 
menthol, camphor (synthetic) cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 67703-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.3 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
COCONUT OIL (UNII: Q9L0O73W7L)  
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
SESAME SEED (UNII: 7Y1255HVXR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 67703-001-001 in 1 PACKAGE01/26/201703/30/2020
140 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/26/201703/30/2020
Labeler - EuroPharma, Inc (060446577)
Registrant - EuroPharma, Inc (060446577)

Revised: 10/2019
Document Id: 95c10c24-b5ca-864d-e053-2995a90a3235
Set id: 49b12d66-26c6-263d-e054-00144ff88e88
Version: 3
Effective Time: 20191025
 
EuroPharma, Inc