Label: ORALABS COLD SORE TREATMENT- benzocaine ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 63645-162-04 - Packager: OraLabs
- Category: HUMAN OTC DRUG LABEL
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 September 4, 2014
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Keep Out of Reach of Children
- Uses
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Warnings
For external use only: Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a physician.
Allergy Alert: Do not use if you are allergic to any of the ingredients in this product.
When using this product avoid contact with eyes. Use only as directed.
Stop use and ask a doctor if the condition gets worse. Do not use longer than 1 week unless directed by a doctor.
- Directions
- Inactive Ingredients
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INGREDIENTS AND APPEARANCE
ORALABS COLD SORE TREATMENT
benzocaine ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63645-162 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 5.00 mg in 1 g Inactive Ingredients Ingredient Name Strength LIGHT MINERAL OIL (UNII: N6K5787QVP) 2.00 mg in 1 g DOCOSANOL (UNII: 9G1OE216XY) 10 mg in 1 g BENZYL ALCOHOL (UNII: LKG8494WBH) 9.00 mg in 1 g SUCROSE STEARATE (UNII: 274KW0O50M) 5.00 mg in 1 g PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 4.99 mg in 1 g WATER (UNII: 059QF0KO0R) 64 mg in 1 g Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63645-162-04 1 g in 1 CONTAINER; 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 08/01/2014 Labeler - OraLabs (801824756) Registrant - OraLabs (801824756) Establishment Name Address ID/FEI Business Operations OraLabs 801824756 MANUFACTURE(63645-162) , LABEL(63645-162)