Label: 4X MEDICATED SEVERE TOOTHACHE AND GUM GEL- benzalkonium chloride gel
- NDC Code(s): 79481-0610-9
- Packager: Meijer
- 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 August 11, 2023
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Benzalkonium chloride 0.13% ..................................Oral antiseptic
Benzocaine 20% .....................................................Oral pain reliever
Menthol 0.5% ........................................................Oral pain reliever
Zinc chloride 0.15% ................................................Oral astringent
- Use
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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 lightheadedness • fatigue or lack of energy
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
• more than directed • for more than 7 days unless told to do so by a dentist or doctor • for teething • in children under 2 years of age
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Directions
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 children under 12 years of age should be supervised in the use of this product • children under a dentist or doctor • 2 years of age: do not use
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Other Information
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 extended duration of relief • avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
- INACTIVE INGREDIENT
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PRINCIPAL DISPLAY PANEL
NDC 41250- 061-19
*Compare to the active ingredient in Orajel™ 4X Medicated For Toothache & Gum Gel
4X MEDICATED
toothache & gum
pain relief gel
Immediate Pain Relief
20% Benzocaine to Relieve Oral Pain
Antiseptic to Kill Harmful Batceria
Astringent to Help Prevent Infection
Menthol to cool Gum & Relieves Irritation
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INGREDIENTS AND APPEARANCE
4X MEDICATED SEVERE TOOTHACHE AND GUM GEL
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-0610 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 g 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 (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) SORBIC ACID (UNII: X045WJ989B) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) SACCHARIN SODIUM (UNII: SB8ZUX40TY) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) Product Characteristics Color blue Score Shape Size Flavor WINTERGREEN Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79481-0610-9 1 in 1 CARTON 11/20/2019 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 not final part356 11/20/2019 Labeler - Meijer (006959555) Establishment Name Address ID/FEI Business Operations Lornamead 080046418 manufacture(79481-0610) , pack(79481-0610)