MYDERM BITE AND STING- benzocaine ointment

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

Benzocaine - 5.0%

PURPOSE

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

INDICATIONS & USAGE

Temporary relief of pain and itching associated with insect bites

WARNINGS

For external use only

When using this product avoid contact with the eye

STOP USE

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MYDERM BITE AND STING 
benzocaine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-038
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-038-01	50 g in 1 TUBE; Type 0: Not a Combination Product	12/14/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	12/14/2021

Labeler - Medline Industries (025460908)

Registrant - Inspec Solutions LLC. (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC.		081030372	manufacture(53329-038)