RECTASMOOTHE- lidocaine 5% cream

RectaSmoothe by

Drug Labeling and Warnings

RectaSmoothe by is a Otc medication manufactured, distributed, or labeled by Leading Pharma, LLC, Lyne Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine 5% w/w

Purpose

Local anesthetic

Uses

Helps relive the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

WARNINGS:

For external use only.

When using this product

• avoid contact with the eyes
• do not exceed recommended dosage unless directed by a doctor
• do not put this product into the rectum by using fingers or any other mechanical device or applicator

Stop use and ask doctor if

• rectal bleeding occurs
• condition worsens or does not improve within 7 days
• allergic reaction occurs to ingredients in this product
• symptom being treated does not suside or if redness, irritation swelling, pain or other symptoms develop or increase
• symptoms clear up and return within a few days

Keep out of the reach of children

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

Directions

• When practical, clean area with mild soap and warm water and rinse thouroughly. 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 six times a day.
• Children under 12 years of age: Consult a doctor
• To use finger cots: Roll one finger cot over finger. FGently squeeze cream onto finger cot. Smooth a layer of the cream over the 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

cetyl alcohol, glyceryl monostearate SE, methylparaben, propylene glycol, propylparaben, purified water, white petrolatum, white wax

Lidocaine 5%

INGREDIENTS AND APPEARANCE

RECTASMOOTHE 
lidocaine 5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69315-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PETROLATUM (UNII: 4T6H12BN9U)
WHITE WAX (UNII: 7G1J5DA97F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69315-301-30	1 in 1 CARTON	05/15/2016
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	04/01/2011

Labeler - Leading Pharma, LLC (079575060)

Registrant - Leading Pharma, LLC (079575060)

Establishment
Name	Address	ID/FEI	Business Operations
Lyne Laboratories, Inc.		053510459	MANUFACTURE(69315-301)