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Ultra Strength Pain Relief Balm

Dosage form: ointment
Ingredients: CAMPHOR (SYNTHETIC) 0.11g in 1g, MENTHOL 0.11g in 1g
Labeler: Universal Distribution Center LLC
NDC Code: 52000-063

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.

Active ingredients Purpose

Camphor 11% ...........................................................................Topical analgesic

Menthol 11% ............................................................................Topical analgesic

Uses

temporary relief of minor aches and pains of muscles and joints related to arthritis, overexertion, simple backache, strains, and sprains

WARNING: EXTERNAL USE ONLY

When using this product

  • Avoid contact with eyes and mucous membranes
  • Do not apply to open wounds or damaged skin
  • Do not bandage or use heating pad

STOP USE and consult a doctor if

  • Condition worsens
  • Severe skin irritation occurs
  • Pain persists for more than seven days
  • Pain clears up and then reoccurs a few days later

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

  • Rub well on the affected area. Repeat 3 to 4 times daily
  • Wash hands with soap and water after applying
  • For children 2-12 years, consult a doctor before use

Other information

This product may cause allergic reaction in some individuals. Test on small area before use.

Inactive Ingredients

cajuput oil, clove oil, dementholized mint oil, paraffin, petrolatum

Distributed by:

Universal Distribution Center

Edison, NJ

www.universaldc.com

Made in P.R.C.

ULTRA STRENGTH PAIN RELIEF BALM 
camphor, menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-063
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)0.11 g  in 1 g
MENTHOL (MENTHOL) MENTHOL0.11 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
CAJUPUT OIL 
PETROLATUM 
PEPPERMINT OIL 
CLOVE OIL 
PARAFFIN 
Packaging
#Item CodePackage Description
1NDC:52000-063-2418 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/01/2017
Labeler - Universal Distribution Center LLC (019180459)

 
Universal Distribution Center LLC

← See all Ultra Strength Pain Relief Balm brands

Medically reviewed on Aug 21, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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