Label: RECTICARE ADVANCED- lidocaine and mineral oil and phenylephrine hcl and white petrolatum cream
- NDC Code(s): 0496-0978-15, 0496-0978-30
- Packager: Ferndale Laboratories, Inc.
- 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 April 12, 2021
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
-
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
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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
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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
- Inactive ingredients
- Package Label
-
INGREDIENTS AND APPEARANCE
RECTICARE ADVANCED
lidocaine and mineral oil and phenylephrine hcl and white petrolatum creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0496-0978 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 50 mg in 1 g MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 170 mg in 1 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 2.5 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 390 mg in 1 g Inactive Ingredients Ingredient Name Strength CETETH-20 (UNII: I835H2IHHX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0496-0978-15 15 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2016 2 NDC:0496-0978-30 30 g in 1 TUBE; Type 0: Not a Combination Product 08/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 04/01/2016 Labeler - Ferndale Laboratories, Inc. (005320536) Establishment Name Address ID/FEI Business Operations Ferndale Laboratories, Inc. 005320536 manufacture(0496-0978)
