Label: KROGER MAXIMUM STRENGTH- benzocaine cream
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Contains inactivated NDC Code(s)
NDC Code(s): 30142-354-02, 30142-354-09 - Packager: Kroger
- Category: HUMAN OTC DRUG LABEL
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 29, 2016
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- Official Label (Printer Friendly)
- 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 other “caine” anesthetics
When using this product
- do not use more than directed
- for more than 7 days unless told to do so by a dentist or doctor
Stop use and ask a doctor if
- swelling rash or fever developes
- irritation, pain or redness persists or worsens
- symptoms do not improve in 7 days
- allergic reaction occurs
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Directions
- cut open tip of tubne on score mark
- adults and children 2 years of age and older; apply a small amount of product to the cavity and arround the gum surrounding the teeth
- use up to 4 times daily or as directed by a dentist or doctor.
- Children under 12 years of age should be supervised in the use of this product.
Children under 2 years of age: ask a dentist or doctor.
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Other Information
- do not use if tip is cut prior to opening
- this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
- do not use continuously
- this formula will stay in place for an extended duration of relief
- avoid using toothpaste or drinking softdrinks or fruit juices for at least one hour after applying
- Inactive ingredients
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KROGER MAXIMUM STRENGTH
benzocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-354 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 20.00 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.25 g in 100 g Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) 0.1 g in 100 g SACCHARIN SODIUM (UNII: SB8ZUX40TY) PETROLATUM (UNII: 4T6H12BN9U) MINERAL OIL (UNII: T5L8T28FGP) GELATIN (UNII: 2G86QN327L) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) METHYL SALICYLATE (UNII: LAV5U5022Y) PECTIN (UNII: 89NA02M4RX) Carboxymethylcellulose Sodium (UNII: K679OBS311) Product Characteristics Color white (off white to beige tan) Score Shape Size Flavor WINTERGREEN (Characteristic wintergreen) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-354-09 1 in 1 CARTON 07/29/2016 1 NDC:30142-354-02 9.3 g in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 07/29/2016 Labeler - Kroger (006999528) Registrant - Lornamead (126440440) Establishment Name Address ID/FEI Business Operations Lornamead 126440440 manufacture(30142-354) , pack(30142-354)