Label: WALGREENS COLD SORE TREATMENT- benzocaine ointment
- 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.
Updated April 1, 2015
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- Active ingredient
- Keep Out of Reach of Children
For external use only: Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butocaine, benzocaine, or other “caine: anesthetics.
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.
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.
- Inactive Ingredients
- Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
WALGREENS COLD SORE TREATMENT
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-3191 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:0363-3191-01 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 04/01/2015 Labeler - Walgreens (008965063) Registrant - Walgreens (008965063) Establishment Name Address ID/FEI Business Operations OraLabs 801824756 MANUFACTURE(0363-3191) , LABEL(0363-3191)