Label: LEMON GLYCERIN- glycerin swab
- NDC Code(s): 67777-161-10, 67777-161-11
- Packager: Dynarex Corporation
- 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 January 23, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
For Oral Use Only. Do not get in eyes.
Do not use
• If you are allergic to any of the ingredients
• On children under 2 years of age unless directed by a doctor or dentist
Stop use and ask a doctor if
• Sore throat is severe, persists for more than 2 days, and is accompanied or followed by fever, headache, rash, nausea, or vomiting
• Sore mouth symptoms do not imrpove in 7 days
- Other information
- Inactive ingredients
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-161 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 0.3 g in 4 g Inactive Ingredients Ingredient Name Strength SODIUM BENZOATE (UNII: OJ245FE5EU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor LEMON (Lemon Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67777-161-10 250 in 1 CASE 12/18/2019 1 NDC:67777-161-11 25 in 1 BOX 1 0.3 g in 1 APPLICATOR; 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 12/18/2019 Labeler - Dynarex Corporation (008124539) Registrant - Dynarex Corporation (008124539)