LIDOCAINE PAIN RELIEF WITH LAVENDER- lidocaine hydrochloride liquid

Lidocaine Pain Relief with Lavender by

Drug Labeling and Warnings

Lidocaine Pain Relief with Lavender by is a Otc medication manufactured, distributed, or labeled by Natural Essentials, Inc., NATURAL ESSENTIALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine HCl 4%

Purpose

Topical anesthetic

Use

• For the temporary relief of pain

Warnings

For external use only

Do not use

• on large areas of the body or on cut, irritated or swollen skin
• on puncture wounds
• for more than one week without consulting a doctor

When using this product

• use only as directed. Read and follow all directions and warnings on this carton
• do not allow contact with the eyes
• do not bandage or apply local heat (such as heating pads) to area of use

Stop use and ask a doctor if

• conditions worsen
• skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
• symptoms persist for more than 7 days
• symptoms dear up and occur again within a few days

Flammable: Keep away from fire or flame

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children and pets.

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

Directions

• adults and children 12 years of age and over:
• apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period

children 12 years or younger:ask a doctor

Other information

• Avoid storing product in direct sunlight
• Protect product from excessive moisture
• Store with lid closed tightly

Inactive ingredients

Acrylates/C10-30 Acrylate Crosspolymer, Alcohol Denatured, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Lavandula Angustifolia (Lavender) Oil, Methylparaben, Polysorbate 60, Steareth-2, Steareth-21, Water

Principal Display Panel – 73 mL Carton Label

CVS
Health ®

Compare to the active
ingredient in Aspercreme ®
Lidocaine with Lavender
Essential Oil*

MAXIMUM STRENGTH
Lidocaine concentration
without a prescription †

Lidocaine
Pain Relief
Roll-On

LIDOCAINE HCI 4%

Lavender Essential Oil

• Temporary relief of pain
• Helps numb pain-affected
  areas without irritation
• Non-greasy, no-mess formula

With calming
lavender
aromatherapy

Actual Bottle
Size on
Side Panel

2.5 FL OZ
(73 mL)

Principal Display Panel – 73 mL Bottle Label

CVS
Health ®

MAXIMUM STRENGTH
Lidocaine concentration
without a prescription †

Lidocaine Pain
Relief Roll-On

LIDOCAINE HCI 4%

Lavender Essential Oil

With calming
lavender
aromatherapy

2.5 FL OZ (73 mL)

INGREDIENTS AND APPEARANCE

LIDOCAINE PAIN RELIEF WITH LAVENDER 
lidocaine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66902-057
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	38 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
ISOHEXADECANE (UNII: 918X1OUF1E)
LAVENDER OIL (UNII: ZBP1YXW0H8)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66902-057-03	1 in 1 CARTON	01/22/2021
1		73 mL in 1 BOTTLE, WITH APPLICATOR; 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	01/22/2021

Labeler - Natural Essentials, Inc. (947484713)

Establishment
Name	Address	ID/FEI	Business Operations
NATURAL ESSENTIALS, INC.		947484713	manufacture(66902-057)