THERAWORX PM NIGHTTIME MAXIMUM STRENGTH PAIN RELIEF- lidocaine hydrochloride liquid

Theraworx PM Nighttime Maximum Strength Pain Relief by

Drug Labeling and Warnings

Theraworx PM Nighttime Maximum Strength Pain Relief by is a Otc medication manufactured, distributed, or labeled by AVADIM HOLDINGS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Lidocaine Hydrochloride 4.00%

Purpose

Topical analgesic

Uses

For temporary relief of pain

Warnings

For external use only.

Do not use

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

When using this product

avoid contact with the eyes.

Stop use and ask a doctor if

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,

ask a health professional before use.

Keep out of reach of children.

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

Directions

• 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

Other Information

Store between 32°F and 120°F

Inactive Ingredients (Alphabetical)

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 Hydrosol, Sodium Benzoate, Tetrasodium EDTA, Xanthan Gum, Yeast Extract, Zingiber (Ginger) Root Extract

This package is child -resistant. Replace cap tightly

Package Labeling:

INGREDIENTS AND APPEARANCE

THERAWORX PM NIGHTTIME MAXIMUM STRENGTH PAIN RELIEF 
lidocaine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61594-044
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508)
SODIUM BENZOATE (UNII: OJ245FE5EU)
EDETATE SODIUM (UNII: MP1J8420LU)
XANTHAN GUM (UNII: TTV12P4NEE)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
GINGER (UNII: C5529G5JPQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61594-044-00	1 in 1 CARTON	09/01/2024
1		74 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/01/2024

Labeler - AVADIM HOLDINGS, INC. (118512488)