Label: RITE AID BABY CARE- benzocaine gel, dentifrice
- NDC Code(s): 11822-1031-2, 11822-1031-9
- Packager: Rite Aid
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient
Benzocaine 7.5% ...................................................................... Oral pain relieverClose
temporarily relieves sore gums due to teething in infants and children 4 months of age and olderClose
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
- Do not use more than directed for more than 7 days unless told to do so 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 do not go away, advise your dentist or doctor.
- Stop use and ask a doctor if sore mouth 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, get medical help or contact a Poison Control Center right away.
- wash hands
- cut open tip of tube on scoremark
- use your fingertip or cotton applicator to apply a small pea-size amount of gel
- apply to affected area up to four times daily or as directed by a dentist or doctor
- for infants under 4 months of age, ask a dentist or doctor
- Other Information
Do not use if tip is cut prior to opening.Close
- Inactive ingredients
FD&C Red 40, Flavor, Glycerin, Polyethylene Glycols, Purified Water, Sodium Saccharin, Sorbic Acid, SorbitolClose
- PRINCIPAL DISPLAY PANEL
- DOSAGE & ADMINISTRATION
• use up to 4 times daily, or as directed by a dentist or doctor • children under 12 years of age should be supervised in
the use of this product • children under 2 years of age: consult a dentist or doctor Close
- INGREDIENTS AND APPEARANCE
RITE AID BABY CARE
benzocaine gel, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-1031 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 7.5 g in 100 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) SORBIC ACID (UNII: X045WJ989B) FD&C RED NO. 40 (UNII: WZB9127XOA) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor CHERRY (Characteristic Cherry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-1031-9 1 in 1 CARTON 1 NDC:11822-1031-2 14.0 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 01/20/2011 Labeler - Rite Aid (014578892) Registrant - Lornamead (126440440) Establishment Name Address ID/FEI Business Operations Lornamead 126440440 manufacture(11822-1031) , pack(11822-1031)