Label: FAMILY WELLNESS ANORECTAL LIDOCAINE- anorectal lidocaine cream
- NDC Code(s): 55319-826-28
- Packager: FAMILY DOLLAR (Family Wellness)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 21, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only.
When using this product
- avoid contact with eyes
- do not exceed recommended dosage unless directed by a doctor
- do not put this product into the rectum by using fingers or any mechanical device or applicator
Stop use and ask a doctor if
- rectal bleeding occurs
- condition worsens or does not improve within 7 days
- allergic reaction occurs to ingredients in this product
- symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
- symptoms clear up and return within a few days
- If pregnant or breastfeeding,ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
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Directions
- 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 externally to the affected area up to 6 times a day.
- Children under 12 years of age: consult a doctor.
- To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.
- Other information
- Inactive ingredient
- Questions 1-800-814-8028
- Principal display panel -Tube
- Principal Display Panel -Carton
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INGREDIENTS AND APPEARANCE
FAMILY WELLNESS ANORECTAL LIDOCAINE
anorectal lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-826 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 PROPYLENE GLYCOL (UNII: 6DC9Q167V3) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) TROLAMINE (UNII: 9O3K93S3TK) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) POLYSORBATE 80 (UNII: 6OZP39ZG8H) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHOLESTEROL (UNII: 97C5T2UQ7J) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-826-28 1 in 1 CARTON 09/30/2023 1 28.3 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 Drug M017 09/30/2023 Labeler - FAMILY DOLLAR (Family Wellness) (024472631)