Label: DCH RAPID RELIEF HEMORRHOIDAL- lidocaine 5%, phenylephrine hydrochloride 0.25% spray
- NDC Code(s): 72839-263-05
- Packager: Derma Care Research Labs
- 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 July 20, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
For external use only.
Flammable--do not use while smoking or near heat or flame.
When using this product avoid contact with eyes, contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120F, do not exceed recommended daily dosage unless directed by a doctor, do not put this product in the rectum by using fingers or any mechanical device or applicator.
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, presently taking a prescription for high blood pressure or depression.
Stop use and ask a doctor if rectal bleeding occurs, the condition worsens or symptoms 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.
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
When practical, cleanse the affected area with mild soap and warm water, rinse thoroughly, and gently pat dry. Spray the affected area, wash hands after 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.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DCH RAPID RELIEF HEMORRHOIDAL
lidocaine 5%, phenylephrine hydrochloride 0.25% sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72839-263 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 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 0.25 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE (UNII: V5VD430YW9) MENTHOL (UNII: L7T10EIP3A) ALCOHOL (UNII: 3K9958V90M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYL GALLATE (UNII: 8D4SNN7V92) SODIUM BENZOATE (UNII: OJ245FE5EU) EDETATE DISODIUM (UNII: 7FLD91C86K) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) MALIC ACID (UNII: 817L1N4CKP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72839-263-05 142 g in 1 CAN; Type 0: Not a Combination Product 02/24/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 02/24/2023 Labeler - Derma Care Research Labs (116817470) Registrant - Derma Care Research Labs (116817470) Establishment Name Address ID/FEI Business Operations Derma Care Research Labs 116817470 manufacture(72839-263)