Label: DOCTOR BUTLERS HEMORRHOID AND FISSURE EXTERNAL PAIN FORMULA- lidocaine 5% ointment
- NDC Code(s): 70942-121-01, 70942-121-11
- Packager: Beyond Health, P.A.
- 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 March 14, 2023
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- Official Label (Printer Friendly)
- 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, or symptoms clear up and return within a few days.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Aesculus Hippocastanum (Horse Chestnut) Extract, Benzyl Alcohol, Calendula Officinalis Flower Extract, Calendula Officinalis flower Extract, Carbomer, Carya Ovata Bark Extract, Centella Asiatica Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cholesterol, Curcuma Longa (Turmeric) Root Extract, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Helichrysum Italicum Extract, Hydrogenated Lecithin, Isopropyl Myristate, Lavandula Angustifolia (Lavender) Flower Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Olea Europaea (Olive) Leaf Extract, Panax Ginseng Root Extract, Polysorbate 80, Propylene Glycol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Hyaluronate, Tocopheryl Acetate, Triethanolamine, Water.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DOCTOR BUTLERS HEMORRHOID AND FISSURE EXTERNAL PAIN FORMULA
lidocaine 5% ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70942-121 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 5 g in 100 g Inactive Ingredients Ingredient Name Strength MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) TURMERIC (UNII: 856YO1Z64F) HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) CARYA OVATA BARK (UNII: X765CF609L) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER 940 (UNII: 4Q93RCW27E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CHOLESTEROL (UNII: 97C5T2UQ7J) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HORSE CHESTNUT (UNII: 3C18L6RJAZ) ASIAN GINSENG (UNII: CUQ3A77YXI) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) ROSEMARY (UNII: IJ67X351P9) MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70942-121-01 28 g in 1 TUBE; Type 0: Not a Combination Product 03/01/2022 2 NDC:70942-121-11 28 g in 1 TUBE; Type 0: Not a Combination Product 03/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 03/01/2022 Labeler - Beyond Health, P.A. (026781064) Registrant - Derma Care Research Labs (116817470) Establishment Name Address ID/FEI Business Operations Derrma Care Research Labs 116817470 manufacture(70942-121)
