Label: ANTISEPTIC PAIN RELIEVING- benzalkonium chloride 0.10% benzocaine 20.00% spray
- 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.
Updated April 27, 2018
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
For external use only.
Flammable: Do not use while smoking or near heat or flame Do not use in large quantities, particularly over raw surfaces or blistered areas
When using this product
• keep out of eyes
• do not apply over large areas of the body or in large quantites. in case of deep or puncture wounds, animal bites, or serious burns, concult a doctor
Stop use and ask doctor if
• condition gets worse • symptoms last more than 7 days
• symptoms clear up and occur again in a few days
•do not use longer than 1 week unless directed by doctor
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ANTISEPTIC PAIN RELIEVING
benzalkonium chloride 0.10% benzocaine 20.00% spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-7779 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride 0.1 g in 100 g Benzocaine (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) Benzocaine 20 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) Diisopropyl Adipate (UNII: P7E6YFV72X) Propylene Glycol (UNII: 6DC9Q167V3) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-7779-03 85 g in 1 CAN; Type 0: Not a Combination Product 07/31/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/31/2017 Labeler - Walgreens (008965063) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(0363-7779) , label(0363-7779)