Label: ORAL PAIN RELIEF- benzocaine and benzalkonium chloride gel
- NDC Code(s): 52000-060-01
- Packager: Universal Distribution Center LLC
- 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 February 21, 2022
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- 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 reduce 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
• fatigue or lack of energyAllergy alert:do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics
- Do not use
- Stop use and ask a physician if
- Keep out of reach of children
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Directions
■ adults and children 2 years of age and over: apply a small amount of the product to the cavity and around the gum surrounding the teeth Use up to 4 times daily or as directed by a physician or healthcare provider
■ 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 information
■ this preparation is intended for use in cases ot toothache, only as a temporary expedient until a physican can be consulted
■ do not use continuously
■ avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening
- Inactive ingredients
- Package Label
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INGREDIENTS AND APPEARANCE
ORAL PAIN RELIEF
benzocaine and benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-060 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 0.2 g in 1 g BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.01 g in 1 g Inactive Ingredients Ingredient Name Strength AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBIC ACID (UNII: X045WJ989B) WATER (UNII: 059QF0KO0R) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52000-060-01 1 in 1 CARTON 12/09/2020 1 14 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 12/09/2020 Labeler - Universal Distribution Center LLC (019180459) Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(52000-060)
