Label: DG 3X MEDICATED TOOTHACHE ADN GUM GEL- benzocaine gel
- NDC Code(s): 55910-816-69
- Packager: Dollar General
- 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 January 23, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
Do not use * more than directed * for more than 7 days uness told to do so by a dentist or doctor * for teething * in children under 2 years of age
Stop use and ask a doctor if * swelling, rash or fever develops * irritation, pain or redness persists or worsens * symptoms do not improve in 7 days * allergeic reaction occurs
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DOSAGE & ADMINISTRATION
cut open tip of tube on score mark * adults and children 2 years of age and older: apply a small amount of product to teh cavity and around 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: do not use
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OTHER SAFETY 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 extended duration of relief * avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying * retain carton for complete product information
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DG 3X MEDICATED TOOTHACHE ADN GUM GEL
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-816 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 20 g in 100 g ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.15 g in 100 g MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 0.26 g in 100 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBIC ACID (UNII: X045WJ989B) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) Product Characteristics Color white (Cloudy White to Yellow) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-816-69 1 in 1 CARTON 10/28/2020 1 9.4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 10/28/2020 Labeler - Dollar General (068331990) Registrant - Lornamead (080046418) Establishment Name Address ID/FEI Business Operations Lornamead 080046418 manufacture(55910-816) , pack(55910-816)
