Drug Labeling and Warnings

Drug Details [pdf]

ULTRA STRENGTH PAIN RELIEF- capsaicin liquid 
Universal Distribution Center 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.

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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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-135
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.0015 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-135-24	40 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2017	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/31/2017	01/01/2019

Labeler - Universal Distribution Center LLC (019180459)

Revised: 10/2019

Document Id: 963f5b40-79ce-518e-e053-2995a90ad87e

34390-5

Set id: 58113333-a2cf-2cd0-e053-2991aa0a35ef

Version: 2

Effective Time: 20191031