Label: 4X MEDICATED TOOTHACHE AND GUM GEL- benzocaine gel, dentifrice
- NDC Code(s): 56062-312-22
- Packager: Publix Super Markets INC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 7, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
pale, gray, or blue colored skin (cyanosis)
headache
rapid heart rate
shortness of breath
dizziness or lightheadness
fatique or lack of energy
Alergy 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
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
cut open tip of tube on score mark
adults and children 2 years of age and older: apply a small amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor.
children between 2 and 12 years of age: ask a doctor before use. Should be supervised in the use of this product
children under 2 years of age: do not use
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
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL
PUBLIX SUPER MARKETS, INC
4X MEDICATED GEL
TOOTHACHE & GUM PAIN RELIEF
- 20% Benzocaine to relieve oral pain
- Kills harmful bacteria
- Astringent to help prevent infection
- Cools gum & relieves irritation
Compare to the active ingredients in Orajel
4X medicated for toothache & Gum gel*
NET WT 0.25OZ (7 g)
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INGREDIENTS AND APPEARANCE
4X MEDICATED TOOTHACHE AND GUM GEL
benzocaine gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-312 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 BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 g ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.15 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) SORBIC ACID (UNII: X045WJ989B) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) METHYL SALICYLATE (UNII: LAV5U5022Y) SACCHARIN SODIUM (UNII: SB8ZUX40TY) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) Product Characteristics Color blue (blue to Blue Green) Score Shape Size Flavor WINTERGREEN Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56062-312-22 1 in 1 CARTON 09/01/2024 1 7 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 Drug M022 09/01/2024 Labeler - Publix Super Markets INC (006922009) Registrant - Lornamead Inc (080046418) Establishment Name Address ID/FEI Business Operations Lornamead 080046418 pack(56062-312) , manufacture(56062-312)