NDC | 0496-0978-15, 0496-0978-30 |
Set ID | 209212a7-7b6e-4b26-9f31-0eeb76f026bf |
Category | HUMAN OTC DRUG LABEL |
Packager | Ferndale Laboratories, Inc. |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist, Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART346 |
- 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
-
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
-
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)