Label: ANECREAM 5 - lidocaine cream
- NDC Code(s): 24357-702-15, 24357-702-30
- Packager: Focus Health Group
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 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 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
- When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting of 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 USP controlled room temperature 20-25C (66-77F).
- Inactive ingredients
benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, tocopheryl acetate, trolamine, water.
- Anecream5 30g Tube Carton
The product package shown below represents a sample of that currently in use. Additional packaging may also be available.
Anecream5 Anorectal Cream
Net. Wt. 30g
Distributed by: Focus Health Group
Knoxville, TN 37919
Anecream5 30g Tube Carton
- INGREDIENTS AND APPEARANCE
lidocaine 5% cream
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:24357-702 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (LIDOCAINE) LIDOCAINE 5 g in 100 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL CARBOMER HOMOPOLYMER TYPE C CHOLESTEROL LECITHIN, SOYBEAN POLYSORBATE 80 PROPYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE, DL- TROLAMINE WATER ISOPROPYL MYRISTATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24357-702-30 1 in 1 CARTON 1 30 g in 1 TUBE 2 NDC:24357-702-15 1 in 1 CARTON 2 15 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 12/20/2011 Labeler - Focus Health Group (826939949) Registrant - DSC Laboratories, Div. of DSC Products Inc. (097807374) Establishment Name Address ID/FEI Business Operations DSC Laboratories, Div. of DSC Products Inc. 097807374 manufacture