RITE AID PAIN RELIEVING- benzocaine 20%, menthol 0.5% spray

Rite Aid Pain Relieving by

Drug Labeling and Warnings

Rite Aid Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzocaine 20%, Menthol 0.5%

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

For the temporary relief of pain and itching associated with sunburn, minor skin irritations, insect bites, scrapes, minor cuts, and minor burns.

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

If swallowed, get medical help or contact a Poison Control Center right away.

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

Acetylated Lanolin Alcohol, Alcohol Denat., Aloe Barbadensis Leaf Extract, Cetyl Acetate, Helianthus Annuus (Sunflower) Seed Oil, PEG-8 Laurate, Polysorbate 85.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RITE AID PAIN RELIEVING 
benzocaine 20%, menthol 0.5% spray

Product 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)