Label: LIDOCREAM 4- lidocaine cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 52763-401-30 - Packager: Golden Touch LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 November 11, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- Uses
-
Warnings
For external use only
When using this product
- Avoid contact with the eyes
- Do not use in large quantities particularly over raw surfaces or blistered areas.
- Do not exceed recommended dosage unless directed by a doctor
Stop use and ask a doctor if- allergic reaction occurs
- condition worsens or does not improve within 7 days
- Symptoms clear up and return within a few days
- notice any unusual effects such as blurred vision, dizziness or drowsiness, difficulty in breathing, trembling, chest pain or irregular heart beat
- Directions
- Inactive ingredients
- Packaging
-
INGREDIENTS AND APPEARANCE
LIDOCREAM 4
lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52763-401 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL OLEATE (UNII: 4PC054V79P) ALCOHOL (UNII: 3K9958V90M) SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52763-401-30 1 in 1 CARTON 1 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 12/01/2010 Labeler - Golden Touch LLC (194284147) Establishment Name Address ID/FEI Business Operations Golden Touch LLC 194284147 manufacture(52763-401)