ULTRA STRENGTH PAIN RELIEF BALM  ULTRA STRENGTH- camphor (synthetic) and menthol ointment 
Velocity Pharma LLC

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.

----------

Ultra strength pain relief balm

Drug Facts

Active IngredientsPurpose
Camphor 11%Topical Analgesic
Menthol 11%Topical Analgesic

Uses

See outer packaging for full uses.

Warnings

For External Use Only

When using this product

  • Use only as directed
  • Avoid contact with eyes and mucous membranes
  • Do not apply to wounds, damaged or irritated skin
  • Do not bandage or cover with wrap or use heating pad
  • Do not use 1 hour prior to bathing or within 30 minutes after bathing.

Stop use and ask a doctor if

  • Condition worsens
  • Severe skin irritation occurs
  • Pain persists for more than 7 days
  • Pain clears up and then recurs a few days later.

If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Other information

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

Inactive Ingredients

Cajuput Oil, Cassia Oil, Clove Oil, Dementholized Mint Oil and Paraffin base.

Questions

1-855-314-1850

bam1bam2

ULTRA STRENGTH PAIN RELIEF BALM   ULTRA STRENGTH
camphor (synthetic) and menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-331
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)110 mg  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM110 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CAJUPUT OIL (UNII: J3TO6BUQ37)  
PADANG CASSIA OIL (UNII: 0E15252LIW)  
CLOVE OIL (UNII: 578389D6D0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76168-331-181 in 1 PACKAGE09/10/2020
118 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/10/2020
Labeler - Velocity Pharma LLC (962198409)
Registrant - Velocity Pharma LLC (962198409)

Revised: 11/2022
Document Id: edf30b05-987d-b701-e053-2a95a90a9849
Set id: 5f791159-c388-4c77-8aca-35e4c3f7cacd
Version: 3
Effective Time: 20221120
 
Velocity Pharma LLC