Rite Aid Cold Sore Treatment by Rite Aid / Ranir LLC BPC 407

Drug Details [pdf]

RITE AID COLD SORE TREATMENT- camphor cream
Rite Aid

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.

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BPC 407 - Rite Aid

Active Ingredient

Benzalkonium Chloride 0.13%

Camphor 3.0%

Purpose

Cold Sore/Fever Blister Treatment/First Aid Antiseptic

Uses

for treatment of cold sores/fever blisters on the face or lips
temporarily relieves the symptoms of itching and pain associated with cold sores/fever blisters
first aid to help protect against infection in minor cuts, scrapes, burns, and First aid to help protect against infection in minor cuts, scrapes, burns, and sores

Warnings

For external use only: 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.
Allergy Alert: Do not use if you are allergic to any of the ingredients in this product.
When using this product avoid contact with eyes. Use only as directed.
Stop use and consult a doctor if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

clean the affected area
apply a small amount of this product to the affected area 1 to 3 times daily
rub in gently
wash hands before and after applying the product
do not share this product with anyone
children under 12 years of age: ask a doctor

Other Information

store at room temperature

Inactive Ingredients

alcohol, aloe barbadensis leaf juice, arginine, butylparaben, cetearyl isononanoate, dipropylene glycol dicaprylate/dicaprate, ethylparaben, eucalyptus globulus leaf oil, hexyl decyl laurate, hexyldecanole, melaleuca alternifolia (tea tree) leaf oil, menthol, methylparaben, ozokerite, phenoxyethanol, poloxamer 407, propylparaben, thymol, tocopheryl nicotinate (vitamin e), zinc chloride

Questions or Comments?

Call us toll-free at 1-877-242-3234 Monday-Friday, 9 a.m. to 5 p.m. EST.
Serious side effects associated with use of this product may be reported to this number.

RITE AID COLD SORE TREATMENT
camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-4070
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	30 mg in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARGININE (UNII: 94ZLA3W45F)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CERESIN (UNII: Q1LS2UJO3A)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
CORYMBIA CITRIODORA LEAF OIL (UNII: M63U6N96EB)
DIPROPYLENE GLYCOL CAPRATE/CAPRYLATE DIESTER (UNII: R6G12EY23X)
ETHYLPARABEN (UNII: 14255EXE39)
HEXYLDECANOL (UNII: 151Z7P1317)
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
LEVOMENTHOL (UNII: BZ1R15MTK7)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TEA TREE OIL (UNII: VIF565UC2G)
THYMOL (UNII: 3J50XA376E)
TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C)
ZINC CHLORIDE (UNII: 86Q357L16B)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 11822-4070-1	1 in 1 PACKAGE	04/05/2013	01/19/2017
1		2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/05/2013	01/19/2017

Labeler - Rite Aid (014578892)

Registrant - Ranir LLC (364567615)

Name	Address	ID/FEI	Business Operations
Establishment
Ranir LLC		364567615	repack(11822-4070) , relabel(11822-4070)

Revised: 11/2019

Document Id: 9716d4bf-f592-035d-e053-2995a90a5521

Set id: b010d6f7-033f-4044-ae52-d87fc37d66c6

Version: 5

Effective Time: 20191111