Drug Labeling and Warnings

Drug Details [pdf]

ULTRA STRENGTH PAIN RELIEF BALM- camphor, menthol ointment 
Essentials Biotech Co, Ltd

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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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.

82716

ULTRA STRENGTH PAIN RELIEF BALM 
camphor, menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71183-063
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.11 g  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.11 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
CAJUPUT OIL (UNII: J3TO6BUQ37)  
PETROLATUM (UNII: 4T6H12BN9U)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
CLOVE OIL (UNII: 578389D6D0)  
PARAFFIN (UNII: I9O0E3H2ZE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71183-063-2418 g in 1 BOTTLE; Type 0: Not a Combination Product09/01/201701/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/01/201701/01/2019
Labeler - Essentials Biotech Co, Ltd (544530742)

Revised: 11/2019