Label: CVS FAST ACTING BABY TEETHING- benzocaine gel
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-829-51 - Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 July 8, 2010
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
Warnings
Allergy alert: do not use this product if your baby has a history of allergy to
local anesthetics such as butacaine, benzocaine, procaine, or other "caine" anesthetics
Do not use - more than directed - for more than 7 days, unless directed by a dentist or doctor
When using this product - fever and nasal congestion are not symptoms of teething
and may indicate the presence of infection. if these symptoms persist, contact your dentist or doctor.
Stop use and consult a dentist or doctor if:
- sore gum symptoms do not get better in 7 days
- irritation, pain or redness does not go away - rash, swelling or fever develops
Keep out of the reach of children. In case of allergic reaction or overdose,
seek medical attention or contact a Poison Control Center immediately. -
DOSAGE & ADMINISTRATION
Directions
- clean hands thoroughly - cut open tip of tube on score line
- use your fingertip or cotton swab to apply a small, pea-size amount of CVS Baby Teething Gel
- apply to the affected area up to four times a day or as directed by a dentist or doctor
- consult a dentist or doctor for infants under 4 months of age
Other information
do not use if tube tip is cut prior to opening
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CVS FAST ACTING BABY TEETHING
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-829 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 75 mg in 1 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) FD&C RED NO. 4 (UNII: X3W0AM1JLX) WATER (UNII: 059QF0KO0R) SORBIC ACID (UNII: X045WJ989B) Product Characteristics Color Score Shape Size Flavor CHERRY (CHERRY FLAVOR) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-829-51 1 in 1 CARTON 1 9.4 g in 1 TUBE, WITH APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 07/08/2010 Labeler - CVS Pharmacy (062312574) Registrant - Pharma Pac, LLC (140807475) Establishment Name Address ID/FEI Business Operations Pharma Pac, LLC 140807475 manufacture
