MYDERM BITE RELIEF- benzocaine ointment 
Inspec Solutions 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.

----------

MyDerm Bite Relief Mediocated Ointment

Active Ingredient:

Benzocaine - 5.0%


Benzocaine - 10.0% ............Pain Relief

Temporary relief of pain and itching associated with insect bites

For external use only

When using this product • avoid contact with the eye

Stop 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.

Direction Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: consult a physician

Aloe Barbadensis Leaf Extract

Camphor

Chamomilla Recutita (Matricaria) Flower Extract

Diazolidinyl Urea

Disodium EDTA

Eugenia Caryophyllus (Clove) Flower Oil

Hydrocortisone

Inactive Ingredients:

Mentha Piperita (Peppermint) Oil

Menthol

Methylparaben

Olea Europaea (Olive) Fruit Oil

Papain

PEG-2 Stearate

PEG-2 Stearate SE

Polyethylene

Propylene Glycol

Propylparaben

SD Alcohol 40

Water

MyDerm Bite Relief

MYDERM BITE RELIEF 
benzocaine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72667-019
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
PEG-2 STEARATE (UNII: 94YQ11Y95F)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
CLOVE OIL (UNII: 578389D6D0)  
PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)  
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
ALOE (UNII: V5VD430YW9)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
ALCOHOL (UNII: 3K9958V90M)  
MEDIUM DENSITY POLYETHYLENE (UNII: 3W404QE89S)  
MENTHOL (UNII: L7T10EIP3A)  
HYDROCORTISONE (UNII: WI4X0X7BPJ)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72667-019-0150 g in 1 TUBE; Type 0: Not a Combination Product12/14/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/14/2021
Labeler - Inspec Solutions LLC. (081030372)
Establishment
NameAddressID/FEIBusiness Operations
Inspec Solutions LLC.081030372manufacture(72667-019)

Revised: 1/2023
Document Id: f1ec46e5-eea5-d623-e053-2a95a90a13c3
Set id: 88615668-16b5-7840-e053-2a95a90a9208
Version: 2
Effective Time: 20230110
 
Inspec Solutions LLC.