Label: LMX5- lidocaine cream
- NDC Code(s): 0496-0883-15, 0496-0883-30, 0496-0883-97
- Packager: Ferndale Laboratories, Inc.
- 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.
Updated October 30, 2018
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- Active ingredient
Lidocaine 5% w/wClose
temporarily relieves pain and itching due to anorectal disordersClose
When using this product
- avoid contact with eyes
- do not exceed recommended dosage unless directed by a doctor
Stop use and ask a doctor if
- rectal bleeding occurs
- condition worsens or does not improve within 7 days
- allergic reaction occurs
- redness, irritation, swelling, pain or other symptoms begin or increase
- symptoms clear up and return within a few days
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
- avoid contact with eyes
- When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
- Adults and Children 12 years and older: Apply to the affected area up to 6 times a day.
- Children under 12 years of age: Consult a doctor.
- Other information
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Close
- Inactive Ingredients
benzyl alcohol, carbomer 940, chloesterol, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, trolamine, and vitamin E acetateClose
- Package Label
Manufactured for Ferndale Healthcare Inc.
Ferndale, MI 48220 U.S.A.
Toll free (888) 548-0900
L.M.X.5® is a registered trademark of Ferndale, IP Inc.
30 gram NDC 0496-0883-30
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0496-0883 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) CHOLESTEROL (UNII: 97C5T2UQ7J) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0496-0883-30 30 g in 1 TUBE; Type 0: Not a Combination Product 10/01/2003 2 NDC:0496-0883-15 15 g in 1 TUBE; Type 0: Not a Combination Product 10/01/2003 3 NDC:0496-0883-97 1 g in 1 POUCH; Type 0: Not a Combination Product 10/01/2003 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 10/01/2003 Labeler - Ferndale Laboratories, Inc. (005320536) Establishment Name Address ID/FEI Business Operations Ferndale Laboratories, Inc. 005320536 manufacture(0496-0883)