Label: OPTIMV ANTI-ITCH MAXIMUM STRENGTH- benzocaine, resorcinol cream
- NDC Code(s): 55758-300-01, 55758-300-07
- Packager: Pharmadel
- 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 June 8, 2022
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Use
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Warnings
For external use only. Avoid contact with the eyes.
Do not use
- this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other –caine anesthetics
- over large areas of the body
- if you have unusual or abnormal vaginal discharge except under the supervision of a physician
- Directions
- Other Information
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Inactive ingredients
aloe, carbomer 1342, cetyl alcohol, cholecalciferol (vitamin D), corn oil, dl-alpha- tocopherol (vitamin E), edetate disodium, fragrance, glyceryl monostearate, isopropyl myristate, isopropyl palmitate, lanolin, methylparaben, mineral oil, PEG-100 stearate, propylene glycol, retinol (vitamin A), stearic acid, stearyl alcohol, trolamine, water.
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INGREDIENTS AND APPEARANCE
OPTIMV ANTI-ITCH MAXIMUM STRENGTH
benzocaine, resorcinol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55758-300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 20 g in 100 g RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL 3 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) CETYL ALCOHOL (UNII: 936JST6JCN) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) RETINOL (UNII: G2SH0XKK91) CORN OIL (UNII: 8470G57WFM) CHOLECALCIFEROL (UNII: 1C6V77QF41) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLPARABEN (UNII: A2I8C7HI9T) CARBOMER 1342 (UNII: 809Y72KV36) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TROLAMINE (UNII: 9O3K93S3TK) STEARIC ACID (UNII: 4ELV7Z65AP) LANOLIN (UNII: 7EV65EAW6H) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55758-300-07 1 in 1 CARTON 06/01/2022 06/01/2022 1 20 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:55758-300-01 1 in 1 CARTON 06/01/2022 2 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/01/2022 Labeler - Pharmadel (030129680)