SOULUS RP RASH AND PAIN- lidocaine hydrochloride cream

Soulus Rp Rash and Pain by

Drug Labeling and Warnings

Soulus Rp Rash and Pain by is a Otc medication manufactured, distributed, or labeled by Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active Ingredient

Lidocaine HCl 0.50%

PURPOSE

Purpose

Topical Anesthetic

INDICATIONS & USAGE

Uses: For temporary relief of pain and itching associated with minor skin irritations and/or insect bites.

WARNINGS

Warnings: For external use only. Avoid contact with eyes. Do not apply to open wounds or damaged skin. If symptoms persist for more than seven days, discontinuing use and consult physician.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, consult physician. Do not bandage tightly.

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding, contact physician prior to use.

DOSAGE & ADMINISTRATION

Directions: Apply directly to effected area. Do not use more than four times per day.

INACTIVE INGREDIENT

Other Ingredients: Other Ingredients: (Organic) Beeswax, Bentonite, Eugenia Caryophyllus (Clove) Flower Oil, Silver Oxide, Simmondsia Chinensis (Jojoba) Seed Oil, Zinc Oxide, Zingiber Officinale (Ginger) Oil.

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Made in USA . Distributed by PURE SOURCE, Inc. Miami, Fl 33172. ph (305) 477-8111

PRINCIPAL DISPLAY PANEL

Soulus Rp

RASH and PAIN

Relieves Skin Irritation and Discomfort

NET WT 1.5oz

INGREDIENTS AND APPEARANCE

SOULUS RP RASH AND PAIN 
lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65121-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
BENTONITE (UNII: A3N5ZCN45C)
CLOVE OIL (UNII: 578389D6D0)
SILVER OXIDE (UNII: 897WUN6G6T)
JOJOBA OIL (UNII: 724GKU717M)
ZINC OXIDE (UNII: SOI2LOH54Z)
GINGER OIL (UNII: SAS9Z1SVUK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65121-100-01	44.36 g in 1 TUBE; Type 0: Not a Combination Product	02/09/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/23/2011

Labeler - Pure Source, LLC (080354456)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(65121-100)