Label: FIRST AID MEDICATED RITE AID- benzalkonium chloride 0.10% benzocaine 20.00% spray
- 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 June 6, 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 the eyes • over large areas of the body • longer than 1 week unless
directed by a doctor.
When using this product • keep out of eyes. Rinse with water to remove. • use only
as directed. • Do not puncture or incinerate. Contents under pressure. Do not store at
temperatures above 120ºF.
Ask a doctor before use if you have • deep or puncture wounds • animal bites
• serious burns
Stop use and ask doctor if • condition worsens • symptoms persist for more than 7
days or clear up and occur again with in a few days • needed for longer than 1 week
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- Questions? 1-800-RITEAID (1-800-748-3243)
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
FIRST AID MEDICATED RITE AID
benzalkonium chloride 0.10% benzocaine 20.00% spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-7801 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:11822-7801-3 85 g in 1 CAN; Type 0: Not a Combination Product 08/03/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/03/2017 Labeler - Rite Aid (014578892) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(11822-7801) , label(11822-7801)