Label: ORAL ANALGESIC- benzocaine liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 41250-703-45 - Packager: Meijer Distribution Inc.
- 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 May 13, 2010
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Uses
Uses temporarily relieves pain due to toothache, canker sores, cold sores, fever blisters, minor irritation of the mouth and gums caused by dentures or orthodontic appliances
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.
Flammable: keep away from fire or flame. Avoid smoking during applications and until product has dried.
When using this product avoid contact with the eyes, do not use more than directed, for more than 7 days unless directed by a dentist or doctor
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Directions
Directions remove imprinted safety seal from bottle cap
Adults and children 2 years of age and over Apply product with cotton swab or clean fingertip to the affected area.
Children under 12 years of age Should be supervised in the use of this product
Use up to 4 times daily or as directed by a dentist or doctor
Children under 2 years of age Ask a dentist or doctor
Other information do not use if imprinted bottle seal is broken or missing prior to opening - Inactive ingredients
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ORAL ANALGESIC MAXIMUM STRENGTH
benzocaine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-703 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 0.2 mL in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SACCHARIN SODIUM (UNII: SB8ZUX40TY) WATER (UNII: 059QF0KO0R) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-703-45 1 in 1 CARTON 1 13.3 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 05/13/2010 Labeler - Meijer Distribution Inc. (006959555) Registrant - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Accupac 071609663 manufacture