HURT BLOCKER PRO  PAIN RELIEF- capsaicin cream 
Concept Laboratories, Inc.

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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HURT BLOCKER PRO
Pain Relief

Drug Facts

Active ingredient

Capsicum Oleoresin 0.0625%
(Containing Capsaicin 0.025%)

Purpose

Pain Relieving

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with

Warnings

For external use only.

  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pad, pack, wrap, hot water bottle or any heating element

When using this product do not get into eyes

  • avoid contact with other mucous membranes

Flammable: Keep from heat and flame.

Discontinue use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

  • if swallowed, get medical help or contact a Poison Control center right away
  • if pregnant or nursing, seek the advice of a health professional before using

Directions

Inactive ingredients

Water (Aqua), SD Alcohol 40-B, Aloe Barbadensis Leaf Juice, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Acrylates Copolymer, Linum Usitatissimum (Linseed) Seed Oil, Euterpe Oleracea Fruit Oil, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Lauryl Laurate, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch, Hydrolyzed Starch Octenylsuccinate, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Phenoxyethanol, DMDM Hydantoin, Iodopropynyl Butylcarbamate.

Questions or comments?

Call 1-888-373-8831

PRINCIPAL DISPLAY PANEL - 106 g Bottle Label

HURT
BLOCKER
PRO

PAIN RELIEF

SUPER HEAT
CAPSAICIN
& PEPPERMINT
TINGLE

OMEGAS 3, 6 & 9

ACAI

& ICE PEARLS

NET WT 3.75 OZ. (106 g)

PRINCIPAL DISPLAY PANEL - 106 g Bottle Label
HURT BLOCKER PRO   PAIN RELIEF
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-246
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin0.25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
LAURYL LAURATE (UNII: GPW77G0937)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
STARCH, CORN (UNII: O8232NY3SJ)  
PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALCOHOL (UNII: 3K9958V90M)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
LINSEED OIL (UNII: 84XB4DV00W)  
ACAI OIL (UNII: Z0W6766A2W)  
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64058-246-4257 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:64058-246-64106 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34805/12/2015
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
NameAddressID/FEIBusiness Operations
Concept Laboratories, Inc.962282612MANUFACTURE(64058-246)

Revised: 6/2015
Document Id: 01fe64fb-6bbc-4b21-a874-1edb73d7d1b2
Set id: 97757905-9023-4e1d-998b-94836074814c
Version: 1
Effective Time: 20150623
 
Concept Laboratories, Inc.