CLINISTAT PAIN RELIEVING - benzocaine and menthol spray 
TheraBrands

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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CliniStat Pain Relieving

Active Ingredients

Active Ingredients                                                               Purpose
Benzocaine USP 20%........................................................Topical Analgesic
Menthol USP 0.5%............................................................Topical Analgesic

Uses:

For temporary relief of pain and itching associated with ▪sunburn▪insect bites ▪minor cuts▪scrapes ▪minor burns ▪minor skin irritations.

Warnings:

For external use only. ▪Avoid contact with eyes, mouth and mucous membranes. ▪Contents flammable. Keep away from fire, open flame and heat. ▪Contents under pressure. Do not puncture or incinerate can.

Allergy Alert:

Do not use this product if you have a history of allergy to local anesthetics like procaine, butacaine, benzocaine, or other “caine” anesthetics.

Do not use:

excessive amounts of this product ▪on broken, blistered, abraded skin or open wounds ▪over large areas of the body. Do not smoke while using this product.

When using this product:

▪do not spray in eyes, on the face or in mouth▪do not inhale ▪intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal ▪use only as directed.

Stop use and ask a doctor if:

▪condition worsens ▪symptoms persist for more than 7 days or clear up and occur again within a few days ▪itching,rash or irritation develops.

Keep out of reach of children

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

Directions:

Adults and children 2 years and older: Apply to affected area not more than 3 to 4 times daily.     Children under 2 years: Consult a doctor    To use this product, hold can 6 to 12 inches away from affected area. Point spray nozzle towards skin and press button to activate spray.

Other Information:

Store at room temperature away from heat.

Inactive Ingredients:

Acetylated Lanolin Alcohol, Aloe Barbadensis Leaf Extract, Butane, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Cetyl Acetate, Hydrofluorocarbon 152a, Methylparaben, Mineral Oil, PEG-8 Laurate,Polysorbate 85

Questions?

www.therabrands.com

Purpose

Topical Analgesic

CliniStat  Hospital Strength with a Caring Touch  Pain Relieving Spray  Benzocaine USP 20%  Menthol USP 0.5%   Relieves pain and itching on contact  Sprays upright and upside down   Net Wt.  1.0 oz [28g]   2012 Distributed by Thera Brands LLC, Morristown, NJ 07960 USA

Product Package Label

Clini Stat
CLINISTAT PAIN RELIEVING 
benzocaine,menthol spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:42739-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE20 g  in 100 g
MENTHOL (MENTHOL) MENTHOL0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN ALCOHOLS 
ALOE VERA LEAF 
BUTANE 
ALKYL (C12-15) BENZOATE 
TRICAPRYLIN 
CETYL ACETATE 
1,1-DIFLUOROETHANE 
METHYLPARABEN 
MINERAL OIL 
PEG-8 LAURATE 
POLYSORBATE 85 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42739-001-0028 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34802/22/2012
Labeler - TheraBrands (965470136)
Establishment
NameAddressID/FEIBusiness Operations
Formulated Solutions, LLC143266687manufacture

Revised: 2/2012
 
TheraBrands