Label: ANESGERM- benzocaine gel
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Contains inactivated NDC Code(s)
NDC Code(s): 10095-001-01 - Packager: World Perfumes, 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 8, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
children under 12 years of age should be supervised in the use of this product. Adults and children 12 years of age and older:
- apply to the affected area up to 4 times a day or as directed by a dentist or doctor
Children under 2 years of age:
- consult a dentist or doctor
Teething Infants 4 months of age and over:
- apply to the affected area up to 4 times daily or as directed by a dentist or doctor
Infants under 4 months of age:
- consult a dentist or doctor
- INDICATIONS & USAGE
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WARNINGS
Warnings
Do not exceed recommended dosage.
Do not use
- for more than 7 days unless directed by a dentist or doctor
- if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics
Stop use and ask a doctor if
- sore mouth symptoms do not improve in 7 days
- infection, pain, or redness persists or worsens
- swelling, rash or fever develops
- fever & nasal congestion are present in teething infants 4 months of age and over
These symptoms may be a sign of infection or a serious condition.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANESGERM
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10095-001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 0.2 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) CLOVE OIL (UNII: 578389D6D0) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10095-001-01 0.5 g in 1 PACKAGE; 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 04/30/2015 Labeler - World Perfumes, Inc (101312044) Establishment Name Address ID/FEI Business Operations World Perfumes, Inc 101312044 manufacture(10095-001)