Label: ZONE 1- lidocaine hcl cream
- NDC Code(s): 80069-014-01
- Packager: Dermal Source, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 1, 2024
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
-
DO NOT USE
Do not use if pregnant or breast-feeding.
Do not use if you have seizures or liver disease.
Do not use if you have a known allergy or sensitivity to any
component of this product. If sensitivity occurs, discontinue
use, immediately cleanse skin and seek medical attention. If
condition worsens or if symptoms persist for more than seven
days or clear up and occur again, discontinue use and consult
a doctor. Do not use in large quantities, particularly over raw
surfaces or blistered areas. Avoid contact with eyes. In case of
contact with eyes, rinse immediately with copious amounts of
eyewash and seek treatment by a medical professional. If
accidentally swallowed, get medical attention immediately. - WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions: Sensitivity test advised prior to use.
Apply a moderately thick layer of cream to intact skin. Discontinue use if
sensitivity occurs. Wait for numbness to develop. For thinner skin (eye
area) wait 10-15 minutes. For thicker skin, best results are obtained
after 1 hour of application. Cleanse area thoroughly before procedure.
- INACTIVE INGREDIENT
- STORAGE AND HANDLING
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ZONE 1
lidocaine hcl creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80069-014 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous 40 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glyceryl Monostearate (UNII: 230OU9XXE4) Peg-100 Stearate (UNII: YD01N1999R) Petrolatum (UNII: 4T6H12BN9U) Stearic Acid (UNII: 4ELV7Z65AP) Cetyl Alcohol (UNII: 936JST6JCN) Xanthan Gum (UNII: TTV12P4NEE) Sodium Hydroxymethylglycinate (UNII: DIG6BWZ9XT) Trolamine (UNII: 9O3K93S3TK) Propylparaben (UNII: Z8IX2SC1OH) Methylparaben (UNII: A2I8C7HI9T) Butylated Hydroxytoluene (UNII: 1P9D0Z171K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80069-014-01 14.1748 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2004 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M015 11/01/2004 Labeler - Dermal Source, Inc. (183535629) Establishment Name Address ID/FEI Business Operations HTO Nevada, Inc. (dba Kirkman) 117115846 manufacture(80069-014)