RectiCare Advanced Hemorrhoidal Wipes

RECTICARE ADVANCED by

Drug Labeling and Warnings

RECTICARE ADVANCED by is a Otc medication manufactured, distributed, or labeled by Ferndale Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RECTICARE ADVANCED- glycerin and lidocaine and phenylephrine hcl cloth 
Ferndale Laboratories, Inc.

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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RectiCare Advanced Hemorrhoidal Wipes

Active ingredients

Glycerin 20%w/w

Lidocaine 5% w/w

Phenylephrine HCl 0.25% w/w

Purpose

Glycerin 20%w/w.........................................Protectant

Lidocaine 5% w/w........................................Local Aneshtetic

Phenylephrine HCl 0.25% w/w.....................Vasoconstrictor

Uses

• helps relieve the pain, itching and burning associated with hemorrhoids
• temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders
• temporarily provides a coating for relief of anorectal discomforts
• temporarily protects irritated areas and inflamed perianal skin

Warnings

For external use only.

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thryoid 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

• avoid contact with eyes
• do not exceed recommended daily 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

• 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

If pregnant or breastfeeding,

ask a doctor before use.

Keep out of reach of children.

If swallowed, get medical help or contact Poison Contol Center right away.

Directions

• When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
• Gently apply wipe to the affected area by patting and then discard.
• adults and children 12 years and older: apply externally to the affected area up to 4 times daily
• children under 12 years of age: consult a doctor

Other information

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Inactive Ingredients

benzyl alcohol, citric acid, purified water

Questions?

Toll free (888) 548-0900

Package Label

RECTICARE ADVANCED 
glycerin and lidocaine and phenylephrine hcl cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0496-0979
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	200 mg  in 1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	2.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0496-0979-76	6 g in 1 POUCH; Type 0: Not a Combination Product	04/01/2016	05/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	04/01/2016	05/31/2019

Labeler - Ferndale Laboratories, Inc. (005320536)

Establishment
Name	Address	ID/FEI	Business Operations
Ferndale Laboratories, Inc.		005320536	manufacture(0496-0979)

Revised: 11/2019

Document Id: 97a36b26-c730-7afc-e053-2995a90a0ea4

34390-5

Set id: 94d07482-60b0-4a45-8f79-9723de3cf1ba

Version: 2

Effective Time: 20191118

 

Ferndale Laboratories, Inc.