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ULTRA STRENGTH PAIN RELIEF by Universal Distribution Center LLC

Medically reviewed on August 31, 2017

Dosage form: liquid
Ingredients: CAPSAICIN 0.0015g in 1mL
Labeler: Universal Distribution Center LLC
NDC Code: 52000-135

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 Ingredient..........................Purpose

Capsaicin 0.15%..........................Topical analgesic

Uses

  • temporarily relieves minor pain related to:
  • arthritis
  • simple backache
  • bruises
  • cramps
  • muscle strains
  • sprains

WARNING: EXTERNAL USE ONLY

When using this product

  • read inside of carton before using
  • use only as directed
  • do not bandage tightly or cover treated area
  • do not use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds, damaged, broken or irritated skin
  • a mild burning sensation may occur upon application but typically disappears in several days
  • if severe burning sensation occurs, discontinue use immediately and read information printed inside carton
  • do not expose the area treated with product to heat or direct sunlight

Stop use and ask a doctor if

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within few days

If pregnant or breast-feeding ask a health 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

Adults and Children over 18 years age

apply to affected area

place the appplicator on the skin and press firmly to dispence the liquid

massage into painful area until thoroughly absorbed

repeat as necessary but no more than 3 to 4 times daily

after applying, wash hands with soap and water

Children 18 years and younger: consult a doctor.

Inactive Ingredients

alcohol, carbomer 940, glycerin, propylene glycol, triethanolamine, water

82717

Made in P.R.C.

www.universaldc.com

Distributed by:

Universal Distribution Center

Edison, NJ 08854

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

ULTRA STRENGTH PAIN RELIEF 
capsaicin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-135
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (CAPSAICIN) CAPSAICIN0.0015 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL 
GLYCERIN 
WATER 
Packaging
#Item CodePackage Description
1NDC:52000-135-2440 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/31/2017
Labeler - Universal Distribution Center LLC (019180459)

 
Universal Distribution Center LLC

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Further information

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

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