Label: LIDOCAINE HYDROCHLORIDE- lidocaine hydrochloride gel
- NDC Code(s): 61010-5000-0, 61010-5000-1
- Packager: Safetec of America, 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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- SPL UNCLASSIFIED SECTION
- Active Ingredient
Lidocaine HCl 2.0%Close
Topical pain reliefClose
Temporary pain relief for minor burnsClose
For external use only
Do not use
- In large quantities, particularly over raw or blistered areas
- near eyes, if this happens rinse thoroughly with water
Stop use and ask doctor if condition worsens or persists for more than 7 days or clears up and occurs again within a few days
Keep out of reach of children.
If swallowed get medical help or contact a Poison Control Center right away
- for adults and children 2 years and older: apply to affected area not more than 4 times daily
- children under 2: do not use, consult a doctor
- Inactive ingredients
aloe vera, carbomer, germaben II, propylene glycol, purified water, menthol, triethanolamine, vitamin E acetateClose
- PRINCIPAL DISPLAY PANEL – 0.125 oz. packet
Pain Relief of
0.125 oz. (3.7 ml)
Reorder no. 50000
SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215
- PRINCIPAL DISPLAY PANEL – 4 oz. bottle
Pain Relief of
4 fl. oz. (118 ml)Close
Reorder no. 50001
- INGREDIENTS AND APPEARANCE
lidocaine hydrochloride gel
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:61010-5000 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lidocaine Hydrochloride (Lidocaine) Lidocaine Hydrochloride 20 mg in 1 g Inactive Ingredients Ingredient Name Strength aloe vera leaf propylene glycol diazolidinyl urea water menthol .alpha.-tocopherol acetate trolamine Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61010-5000-0 3.3 g in 1 PACKET 2 NDC:61010-5000-1 121.2 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/19/2012 Labeler - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE(61010-5000)