Soulus Rp Rash and Pain

Manufacturer: Pure Source, LLC
Effective date: 2023-11-10
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-01 21:21:08

Label at a glance#

ProductSoulus Rp Rash and Pain

Active ingredientLIDOCAINE HYDROCHLORIDE

Label structure11 sections

Contacts and useful links#

PhoneLabel contact(305) 477-8111

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Lidocaine HCl 0.50%

OTC - PURPOSE SECTION

Purpose

Topical Anesthetic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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. Warnings:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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.

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Soulus Rp

RASH and PAIN

Relieves Skin Irritation and Discomfort

NET WT 1.5oz

SoulusRp

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
LIDOCAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V13007Z41A	1
LIDOCAINE	ACTIVE MOIETY	98PI200987	1
BENTONITE	INACTIVE INGREDIENT	A3N5ZCN45C	1
CLOVE OIL	INACTIVE INGREDIENT	578389D6D0	1
GINGER OIL	INACTIVE INGREDIENT	SAS9Z1SVUK	1
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	1
SILVER OXIDE	INACTIVE INGREDIENT	897WUN6G6T	1
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	1
ZINC OXIDE	INACTIVE INGREDIENT	SOI2LOH54Z	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

Soulus Rp Rash and Pain
LIDOCAINE HYDROCHLORIDE
YELLOW WAX
BENTONITE
CLOVE OIL
SILVER OXIDE
JOJOBA OIL
ZINC OXIDE
GINGER OIL
LIDOCAINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65121-100	65121-100-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
YELLOW WAX	2ZA36H0S2V	IACT
BENTONITE	A3N5ZCN45C	IACT
CLOVE OIL	578389D6D0	IACT
SILVER OXIDE	897WUN6G6T	IACT
JOJOBA OIL	724GKU717M	IACT
ZINC OXIDE	SOI2LOH54Z	IACT
GINGER OIL	SAS9Z1SVUK	IACT
LIDOCAINE HYDROCHLORIDE	V13007Z41A	ACTIR

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 29 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
BENTONITE	BENTONITE	A3N5ZCN45C	POWDER / TOPICAL	0.67 mg/mg		Exact identifier — unii candidate 11 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	LOTION / TOPICAL	5 %w/w		Exact identifier — unii candidate 11 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	POWDER, DENTIFRICE / DENTAL	0.05 mg/mg		Exact identifier — unii candidate 11 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	SUSPENSION / ORAL	65 mg/5ml		Exact identifier — unii candidate 11 equally ranked IID candidates
CLOVE OIL	CLOVE OIL	578389D6D0	ELIXIR / ORAL	0.42 mg/5ml		Exact identifier — unii candidate 3 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CAPSULE / ORAL		44 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	TABLET / ORAL	355 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CAPSULE, EXTENDED RELEASE / ORAL	80.67 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	SHAMPOO, SUSPENSION / TOPICAL	3.25 %w/v		Exact identifier — unii candidate 11 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	SOLUTION / RESPIRATORY (INHALATION)	3.11 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	TABLET, COATED / ORAL	1.8 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, COATED / ORAL	213.7 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	CAPSULE / ORAL	ADJ PH		Exact identifier — unii candidate 11 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	INJECTION, SUSPENSION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 6 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET / ORAL	3.22 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
CLOVE OIL	CLOVE OIL	578389D6D0	SUSPENSION / ORAL	0.1 mg/5ml		Exact identifier — unii candidate 3 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, DELAYED RELEASE / ORAL	0.1 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CREAM / TOPICAL	5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	CREAM / TOPICAL	4.1 %w/w		Exact identifier — unii candidate 11 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	SUPPOSITORY / RECTAL	375 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
CLOVE OIL	CLOVE OIL	578389D6D0	PASTE, DENTIFRICE / DENTAL	2.4 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	SYSTEM / TRANSDERMAL	9.86 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	INJECTION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	SOLUTION / INTRAVENOUS	3.11 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	SUPPOSITORY / VAGINAL	288.1 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	LOTION / TOPICAL	16 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
25488951-b229-fccc-e063-6394a90a674b			5ad3ad36-e814-4707-9f0d-c0be3ad8f166	2024-10-25	Warnings	Exact identifier spl set id: 5ad3ad36-e814-4707-9f0d-c0be3ad8f166

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.