Label: ORAJEL FOR TOOTHACHE MAXIMUM STRENGTH- benzocaine swab
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Contains inactivated NDC Code(s)
NDC Code(s): 10237-705-12 - Packager: Church & Dwight Co., 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 August 11, 2010
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredient Purpose
Benzocaine 20% Oral Pain RelieverWarnings
Allergy Alert
do not use this product if your 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 unless told to do so by a dentist or doctor
Stop use and ask a dentist of doctor if symptoms do not get better in 7 days; swelling, rash or fever develops; irritation, pain or redness persists or worsens
Keep out of reach of children. in case of overdose or allergic reaction, get medical help or contact a Poison Control Center right awayEnter section text hereDirections
Adults and Children Hold swab with solid white tip down
2 years of age and older Bend and snap open swab tip with the colored rings
Apply product to the cavity and around gum surrounding the teeth
Use up to 4 times daily or as directed by a dentist or doctor
Discard swab after application
Children under 12 years of age Should be supervised in the use of this product
Children under 2 years of age Ask a dentist or doctor
Other information do not use if label seal is broken prior to purchase, or if colored rings on tip are not blue, this preparation is intended for use in cases of toothache, only as temporary expedient until a dentist can be consulted, do not use continuously
Inactive ingredients flavor, polyethylene glycol, purified water, red 40, sodium saccharin, yellow 5
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INGREDIENTS AND APPEARANCE
ORAJEL FOR TOOTHACHE MAXIMUM STRENGTH
benzocaine swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-705 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 POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) FD&C RED NO. 40 (UNII: WZB9127XOA) SACCHARIN SODIUM (UNII: SB8ZUX40TY) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-705-12 12 in 1 CARTON 1 1.8 mL in 1 APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 08/11/2010 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations SwabPlus, Inc. 876441549 manufacture
