RECTICARE COMPLETE- lidocaine and phenylephrine hcl and glycerin and mineral oil and white petrolatum 
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 Complete Hemorrhoid Care System

RECTICARE ADVANCED HEMORRHOIDAL CREAM
Active ingredients

Lidocaine 5% w/w
Mineral Oil 17% w/w
Phenylephrine HCl 0.25% w/w
White Petrolatum 39% w/w

Purpose

Lidocaine 5% w/w................................Local anesthetic
Mineral Oil 17% w/w............................Protectant
Phenylephrine HCl 0.25% w/w.............Vasoconstrictor
White Petrolatum 39% w/w.................Protectant

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
  • 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

  • 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 a Poison Control Center right away.

Directions

  • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
  • 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
  • To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.

Other information

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

Inactive ingredients

ceteth 20, cetostearyl alcohol, citric acid, propylparaben, purified water

***********************************************************************
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 anesthetic
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
  • 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

  • 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 a Poison Control 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 Display

RectiCareCompleteCartonFront

RectiCareCompleteCartonPanelsAB

RectiCareCompleteCartonPanelsCD

RECTICARE COMPLETE 
lidocaine and phenylephrine hcl and glycerin and mineral oil and white petrolatum kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0496-0985
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0496-0985-151 in 1 CARTON; Type 1: Convenience Kit of Co-Package04/01/201605/31/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 15 g
Part 28 POUCH 48 g
Part 1 of 2
RECTICARE ADVANCED 
lidocaine and mineral oil and phenylepherine hcl and white petrolatum cream
Product Information
Item Code (Source)NDC:0496-0978
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL170 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE2.5 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM390 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETETH-20 (UNII: I835H2IHHX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0496-0978-1515 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/01/2016
Part 2 of 2
RECTICARE ADVANCED 
glycerin and lidocaine and phenlyephrine hcl cloth
Product Information
Item Code (Source)NDC:0496-0979
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN200 mg  in 1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE2.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0496-0979-766 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/01/201605/31/2019
Labeler - Ferndale Laboratories, Inc. (005320536)
Establishment
NameAddressID/FEIBusiness Operations
Ferndale Laboratories, Inc.005320536manufacture(0496-0985, 0496-0978, 0496-0979)

Revised: 10/2019
 
Ferndale Laboratories, Inc.