DCH RAPID RELIEF HEMORRHOIDAL- lidocaine 5%, phenylephrine hydrochloride 0.25% spray 
Derma Care Research Labs

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.

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DCH Rapid Relief Hemorrhoidal Spray

Lidocaine 5%, Phenylephrine HCl 0.25%,

Topical Anesthetic, Vasoconstrictor

Helps relieve the local itching and discomfort associated with anorectal disorders or inflammation.

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.

Ask a healthcare or professional before use.

If swallowed, seek medical help or contact a Poison Control Center right away.

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.

Alcohol, Aloe Barbadensis Leaf Extract, Citric Acid, Disodium EDTA, Glycerin, Malic Acid, Menthol, Propyl Gallate, Propylene Glycol, Sodium Benzoate, Water.

Label

DCH RAPID RELIEF HEMORRHOIDAL 
lidocaine 5%, phenylephrine hydrochloride 0.25% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-263
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE0.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72839-263-05142 g in 1 CAN; Type 0: Not a Combination Product02/24/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34602/24/2023
Labeler - Derma Care Research Labs (116817470)
Registrant - Derma Care Research Labs (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs116817470manufacture(72839-263)

Revised: 7/2023
Document Id: 00eef84c-a72f-3343-e063-6294a90aa4d8
Set id: 00eef84c-a72e-3343-e063-6294a90aa4d8
Version: 1
Effective Time: 20230720
 
Derma Care Research Labs