PAIN, BURN, AND ITCH RELIEF- benzocaine 20%, menthol 0.5% spray 
Derma Care Research Labs, 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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DCH Pain, Burn, Itch Spray

Benzocaine 20%, Menthol 0.5%


Topical Analgesic

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

For external use only. Flammable--Keep away from fire or flame. Allergyalert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics. When using this product avoid contact with eyes. Do not spray in the face or mouth. Use only as directed. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120F. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days, itching, rash or irritation develops.

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

Adults and children 2 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor. To use this product, hold the can 6 to 12 inches away from the affected area. Direct spray nozzle towards skin and press the button to activate the spray. To apply to face, spray into palm of hand and gently apply.

Acetylated Lanolin Alcohol, Alcohol Denat., Aloe Barbadensis Leaf Extract, Cetyl Acetate, Helianthus Annuus (Sunflower) Seed Oil, PEG-8 Laurate, Polysorbate 85.

Label

PAIN, BURN, AND ITCH RELIEF 
benzocaine 20%, menthol 0.5% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-343
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)  
ALCOHOL (UNII: 3K9958V90M)  
CETYL ACETATE (UNII: 4Q43814HXS)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
POLYSORBATE 85 (UNII: A7F3N56197)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72839-343-0385 g in 1 CAN; Type 0: Not a Combination Product01/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/30/2023
Labeler - Derma Care Research Labs, LLC (116817470)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(72839-343)

Revised: 6/2023
Document Id: fd9fe09f-3aea-c5f5-e053-6394a90ad691
Set id: fd9fe09f-3ae9-c5f5-e053-6394a90ad691
Version: 1
Effective Time: 20230608
 
Derma Care Research Labs, LLC