Label: HEMORRHOIDAL RELIEF CREAM- lidocaine cream
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Contains inactivated NDC Code(s)
NDC Code(s): 73622-3077-5 - Packager: CURETECH SKINCARE
- 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 10, 2021
If you are a consumer or patient please visit this version.
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Drug Facts
Uses
- Helps relieve the anorectal symptoms associated with hemorrhoids (pain, soreness, burning)
- Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders
Ask a doctor before use if you have
- heart Disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
- presently taking a prescription drug for high blood pressure or depression
When using this product
- do not exceed recommended daily usage 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:
- bleeding occurs
- condition worsens or does not improve within 7 days
- an allergic reaction develops
- if symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
Keep out of reach of children:
If swallowed, seek medical help or contact a Poison Control Center right away
Directions
- adults: when possible, clean affected area with mild soap or warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use
- to use dispensing cap, attach it to the tube, lubricate well, then gentle insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse dispensing cap after use with mild soap and warm water and rinse thoroughly
- apply to affected area upto 4 times daily, especially at night, when waking up and after each bowel movement
Children under 12 years of age: ask a doctor
Inactive ingredients
.Alpha.-Tocopherol Acetate, Aloe Vera Leaf, Asian Ginseng, Calendula officinalis Flower, Chamomile, Chlorocresol, Cholecalciferol, Coconut Oil, Corn Oil, Dimethicone, Fragrance, Hyaluronate Sodium, Hydrocortisone, Lysine Hydrochloride, menthol, Mineral Oil, Petrolatum, Propylene Glycol, Pyridoxine Hydrochloride, Sunflower Oil, Tricaprilin, Vitamin A Palmitate, yellow Wax, Zinc Oxide
- Principal Display & Drug Fact Panel
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INGREDIENTS AND APPEARANCE
HEMORRHOIDAL RELIEF CREAM
lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73622-3077 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 0.25 g in 100 g LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ASIAN GINSENG (UNII: CUQ3A77YXI) CHAMOMILE (UNII: FGL3685T2X) CHLOROCRESOL (UNII: 36W53O7109) CHOLECALCIFEROL (UNII: 1C6V77QF41) CORN OIL (UNII: 8470G57WFM) DIMETHICONE (UNII: 92RU3N3Y1O) HYALURONATE SODIUM (UNII: YSE9PPT4TH) LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) YELLOW WAX (UNII: 2ZA36H0S2V) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) COCONUT OIL (UNII: Q9L0O73W7L) HYDROCORTISONE (UNII: WI4X0X7BPJ) ZINC OXIDE (UNII: SOI2LOH54Z) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) TRICAPRILIN (UNII: 6P92858988) MENTHOL (UNII: L7T10EIP3A) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) SUNFLOWER OIL (UNII: 3W1JG795YI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73622-3077-5 28.3 g in 1 TUBE; Type 0: Not a Combination Product 03/04/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 03/04/2021 Labeler - CURETECH SKINCARE (677682180)