Theraworx PM Nighttime Maximum Strength Pain Relief Roll-On

Manufacturer: AVADIM HOLDINGS, INC.
Effective date: 2026-10-08
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: daily-update
Hydrated at: 2026-10-17 02:02:34

Label at a glance#

ProductTheraworx PM Nighttime Maximum Strength Pain Relief

Active ingredientLIDOCAINE HYDROCHLORIDE

Label structure7 sections

Indications and uses

For temporary relief of pain

Dosage and administration

• Adults and children 2 years of age and older: • shake bottle well • roll a thin layer to each affected area and allow to air dry • repeat • Wash hands after applying product • do not use more than 3 to 4 times daily • children under 2 years of age do not use: consult a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride 4.00%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

in large quantities, particularly over raw surfaces or bilstered areas.

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Other Information

SPL UNCLASSIFIED SECTION

Store between 32°F and 120°F

Inactive Ingredients (Alphabetical)

INACTIVE INGREDIENT SECTION

Allantoin, Aloe barbadensis Leaf Extract, Aqua(Water), Benzyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Decyl Glucoside, Dimethyl Sulfoxide, Ethylhexylglycerin, Glycerin, Parfum (Fragrance), Potassium Sorbate, Sanguinaria canadensis Root Extract, Silver, Sodium Benzoate, Tetrasodium EDTA, Xanthan Gum, Yeast Extract, Zingiber (Ginger) Root Extract

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label7

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0850060284182	GTIN-13: 0850060284182 EAN-13: 0850060284182 GTIN-12: 850060284182 UPC-A: 850060284182 GTIN storage (14 digits): 00850060284182	Label7.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61594-044-00	ML - Milliliter	61594-044	c0b6419a-4f81-47b1-b6ba-bcde30b73862	1	2024-10-04

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

Theraworx PM Nighttime Maximum Strength Pain Relief
LIDOCAINE HYDROCHLORIDE
LIDOCAINE
ALLANTOIN
ALOE VERA LEAF
WATER
BENZYL ALCOHOL
CITRIC ACID MONOHYDRATE
COCAMIDOPROPYL BETAINE
DECYL GLUCOSIDE
DIMETHYL SULFOXIDE
ETHYLHEXYLGLYCERIN
GLYCERIN
POTASSIUM SORBATE
SANGUINARIA CANADENSIS ROOT
SILVER
SODIUM BENZOATE
EDETATE SODIUM
XANTHAN GUM
YEAST, UNSPECIFIED
GINGER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61594-044	61594-044-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LIDOCAINE HYDROCHLORIDE	V13007Z41A	ACTIR
ALLANTOIN	344S277G0Z	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
WATER	059QF0KO0R	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
COCAMIDOPROPYL BETAINE	5OCF3O11KX	IACT
DECYL GLUCOSIDE	Z17H97EA6Y	IACT
DIMETHYL SULFOXIDE	YOW8V9698H	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
GLYCERIN	PDC6A3C0OX	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
SANGUINARIA CANADENSIS ROOT	N9288CD508	IACT
SILVER	3M4G523W1G	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
EDETATE SODIUM	MP1J8420LU	IACT
XANTHAN GUM	TTV12P4NEE	IACT
YEAST, UNSPECIFIED	3NY3SM6B8U	IACT
GINGER	C5529G5JPQ	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
2	2024-09-19	full-release	2026-06-01 00:19:54

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
Theraworx PM Nighttime Maximum Strength Pain Relief	LIDOCAINE HYDROCHLORIDE	AVADIM HOLDINGS, INC.	bc8cb476-9a47-47b3-ad78-a6ecec9ee66f	2024-09-19	Warnings	Exact identifier ndc (package): 61594-044-00 ndc (product): 61594-044 ndc11 (package): 61594004400 spl set id: bc8cb476-9a47-47b3-ad78-a6ecec9ee66f

Reported adverse events (FAERS/openFDA)#

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