CERTUS STING RELIEF PREP PAD - benzocaine swab 
Certus Medical, 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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Certus Sting Relief Prep Pad 210004 Drug Facts and Label

Drug Facts Box OTC Active Ingredient Section

Benzocaine 6%

Drug Facts Box OTC Purpose Section

Topical Anesthetic

Drug Facts Box OTC Indications & Usage Section

For temporary relief of pain and itching associated with minor burns, scrapes and insect bites

 

Drug Facts Box OTC Warnings Section

for external use only
flammable, keep away from fire or flame

Drug Facts Box OTC Do Not Use Section

in the eyes

if contact occurs, flush eyes with water

Drug Facts Box OTC Keep Out of Reach of Children Section

if swallowed get medical help or contact a Poison Control Center right away

Drug Facts Box OTC Dosage & Administration Section

apply to affected area not more than 3 to 4 times daily, for adults and children 2 years of age or older

children under 2 years: consult physician

Drug Facts Box OTC General Precautions Section

Store at room temperature 150 - 300 C (590 - 860 F)

Drug Facts Box OTC Inactive Ingredient Section

isopropyl alcohol, purified water

Certus Sting Relief Prep Pad 210004 pouch

210004.jpg  Certus Sting Relief Prep Pad  pouch  image of pouch label

CERTUS STING RELIEF PREP PAD 
benzocaine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75990-7008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.06 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75990-7008-30.6 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34805/01/2011
Labeler - Certus Medical, Inc. (966433653)

Revised: 4/2011
Document Id: ecba17ad-283a-422b-9d84-3a19cc9783c9
Set id: bd5a1262-4498-4453-a6f9-d45d08ea7d6b
Version: 1
Effective Time: 20110408
 
Certus Medical, Inc.