Label: FAMILY DOLLAR ORAL PAIN RELIEF- benzocaine liquid
- NDC Code(s): 55319-388-82
- Packager: Family Dollar Services 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 June 13, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
- pale, gray, or blue colored skin(cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy
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
- for teething
- in children under 2 years of age
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FAMILY DOLLAR ORAL PAIN RELIEF
benzocaine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-388 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 20 g in 100 g Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) BENZYL ALCOHOL (UNII: LKG8494WBH) SACCHARIN SODIUM (UNII: SB8ZUX40TY) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) WATER (UNII: 059QF0KO0R) METHYLPARABEN (UNII: A2I8C7HI9T) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color orange (orange to reddish orange) Score Shape Size Flavor PINEAPPLE (Pina Colada Flavor 26041) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-388-82 1 in 1 CARTON 08/01/2013 03/23/2023 1 14.7 g in 1 BOTTLE; 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 08/01/2013 Labeler - Family Dollar Services Inc. (024472631) Registrant - Lornamead (078584069) Establishment Name Address ID/FEI Business Operations CSR Cosmetic Solutions Inc. 243501959 manufacture(55319-388)
FAMILY WELLNESS