Label: MYDERM BITE RELIEF- benzocaine ointment
- NDC Code(s): 72667-019-01
- Packager: Inspec Solutions LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 10, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
-
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 RELIEF
benzocaine ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72667-019 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) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72667-019-01 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 not final part348 12/14/2021 Labeler - Inspec Solutions LLC. (081030372) Establishment Name Address ID/FEI Business Operations Inspec Solutions LLC. 081030372 manufacture(72667-019)