Label: RITE AID PAIN RELIEVING- benzocaine 20%, menthol 0.5% spray
- NDC Code(s): 11822-1343-3
- Packager: Rite Aid
- 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 July 1, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
For external use only. Flammable--Keep away from fire or flame. Allergyalert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics. When using this product avoid contact with eyes. Do not spray in the face or mouth. Use only as directed. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120F. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days, itching, rash or irritation develops.
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Adults and children 2 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor. To use this product, hold the can 6 to 12 inches away from the affected area. Direct spray nozzle towards skin and press the button to activate the spray. To apply to face, spray into palm of hand and gently apply.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RITE AID PAIN RELIEVING
benzocaine 20%, menthol 0.5% sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-1343 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 MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P) ALCOHOL (UNII: 3K9958V90M) CETYL ACETATE (UNII: 4Q43814HXS) SUNFLOWER OIL (UNII: 3W1JG795YI) PEG-8 LAURATE (UNII: 762O8IWA10) POLYSORBATE 85 (UNII: A7F3N56197) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-1343-3 85 g in 1 CAN; Type 0: Not a Combination Product 03/31/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/31/2021 Labeler - Rite Aid (014578892) Registrant - Derma Care Research Labs, LLC (116817470) Establishment Name Address ID/FEI Business Operations Derma Care Research Labs, LLC 116817470 manufacture(11822-1343)
