Label: TOPCARE SORE THROAT CHERRY FLAVOR- benzocaine, menthol lozenge
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Contains inactivated NDC Code(s)
NDC Code(s): 36800-813-18 - Packager: Topco Associates LLC
- 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 February 26, 2014
If you are a consumer or patient please visit this version.
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- TopCare Sore Throat Cherry Flavor
- ACTIVE INGREDIENT
- Uses
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Warnings
Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or any other "caine" anesthetics.
- Directions
- Other information
- Inactive ingredients
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TopCare Sore Throat Lozenges Cherry Flavor 18 Count (36800-813-18)
TopCare
FAST-ACTING RELIEF
Sore Throat
Lozenges
MENTHOL • BENZOCAINE
ORAL ANESTHETIC
• Fast, soothing, temporary
relief of minor sore throat
pain and Irritation
Cherry Flavor
COMPARE TO CEPACOL
active ingredients
18 LOZENGES
DISTRIBUTED BY
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
1-888-423-0139 ©TOPCO BSS3114
This product is not manufactured or distributed
by Reckftt Bencldser owner af the registered
trademark Cepacol.
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INGREDIENTS AND APPEARANCE
TOPCARE SORE THROAT CHERRY FLAVOR
benzocaine, menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-813 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 15 mg MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 3.6 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) CORN SYRUP (UNII: 9G5L16BK6N) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) SOYBEAN OIL (UNII: 241ATL177A) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color red Score no score Shape ROUND Size 23mm Flavor CHERRY Imprint Code B Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-813-18 18 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 02/25/2014 Labeler - Topco Associates LLC (006935977) Establishment Name Address ID/FEI Business Operations Bestco, Inc. 002149136 manufacture(36800-813)