Label: DUANE READE BURN RELIEF PAIN RELIEVING GEL- lidocaine hydrochloride gel
- NDC Code(s): 67732-406-16
- Packager: DUANE READE INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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
Lidocaine HCl 0.50%
- temporary pain relief
- helps relieve and soothes pain from sunburn, minor burns, cuts, scrapes, skin irritations and insect bites.
For external use only
Do not use in large quantities, particularly over raw surfaces or blistered areas.
stop use and ask a doctor if
- Conditions worsens or symptoms persists for more than 7 days.
- Symptoms clear up and occur again within a few days.
Keep out of reach of children.
If swallowed get medical help or contact a Poison Control Center right away.
- adults and children 2 years of age and older.apply to affected area not more than 3 to 4 times daily
- children under 2 years of age: do not use, ask a doctor.
- Inactive Ingredients
Aloe Barbadensis Leaf Juice, Water, Propylene Glycol, Glycerin, Isopropyl Alcohol, Triethanolamine, Polysorbate 80, Carbomer, Diazolidinyl urea, Disodium EDTA, Menthol, Yellow 5, Blue 1.Close
- Principal Display Panel
UNIQUELY NY DRTM SINCE 1960burn
pain relieving gel
NET WT 8 OZ (227 g)
- INGREDIENTS AND APPEARANCE
DUANE READE BURN RELIEF PAIN RELIEVING GEL
lidocaine hydrochloride gel
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67732-406 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER TROLAMINE ISOPROPYL ALCOHOL EDETATE DISODIUM ALOE VERA LEAF PROPYLENE GLYCOL GLYCERIN POLYSORBATE 80 DIAZOLIDINYL UREA MENTHOL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67732-406-16 226 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/13/2012 Labeler - DUANE READE INC. (011988995)