- 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)