Nervive™ Pain Relieving Liquid Roll-on

Nervive™ Pain Relieving Liquid Roll-on
SPL v5
SPL
SPL Set ID 1e8aeccc-8d00-9886-e063-6394a90ad7a6
Route
TOPICAL
Published
Effective Date 2024-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g) Menthol (1 g)
Inactive Ingredients
Dimethicone Caprylyl Trisiloxane Carbomer Interpolymer Type B (allyl Pentaerythritol Crosslinked) Aminomethylpropanol Phenoxyethanol Steareth-21 Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Isohexadecane Ethylhexylglycerin Ceteth-20 Phosphate Glyceryl Monostearate Alcohol Cetostearyl Alcohol Sorbitan Isostearate Polysorbate 60 Tocopherol C30-45 Alkyl Cetearyl Dimethicone Crosspolymer Edetate Disodium Water Dihexadecyl Phosphate Steareth-2

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-12

Description

Drug Facts

Purpose

Topical anesthetic Topical analgesic


Medication Information

Purpose

Topical anesthetic Topical analgesic

Description

Drug Facts

Use

temporarily relieves minor pain

Section 34088-5

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children and pets.

Warnings

For external use only



Flammable

  • keep away from heat and open flame
Directions

Shake well before use

adults and children over 12 years:

  • apply a thin layer to affected area every 6 to 8 hours
  • do not exceed 3 applications in a 24 hour period
  • massage into painful area until thoroughly absorbed into skin

AFTER APPLYING, WASH HANDS WITH SOAP AND WAT ER

children 12 years or younger: ask a doctor

Store at no greater than 25°C (77°F).

Do Not Use

• If you have had an allergic reaction to lidocaine or other local anesthetics



• on large areas of the body or on cut, irritated, blistered, or swollen skin



• on puncture wounds



• for more than one week without consulting a doctor

Questions?

1-855-446-4345

Active Ingredients

Lidocaine HCl 4%

Menthol 1%

Inactive Ingredients

alcohol, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, carbomer homopolymer, ceteth-20 phosphate, cetearyl alcohol, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexyl glycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, polysorbate 60, sorbitan isostearate, steareth-2, steareth-21, tocopherol, water

When Using This Product

• use only as directed. Read and follow all directions and warnings on this carton.



• avoid contact with eyes and mucous membranes



• rare cases of serious burns have been reported with products of this type



• do not apply to wounds or damaged, broken or irritated skin



• do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use



• a transient burning sensation may occur upon application but generally disappears in several days



• avoid applying into skin folds

Active Ingredients Purpose

Topical anesthetic

Topical analgesic

Stop Use and Ask A Doctor If

• condition worsens

• severe burning sensation, redness, rash or irritation develops

• symptoms persist for more than 7 days or clear up and occur again within a few days

• you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If Pregnant Or Breast Feeding,

ask a health professional before use.

Principal Display Panel 2.5 Oz

NERVIVE™

PAIN RELIEVING

LIQUID ROLL-ON

LIDOCAINE HCl & MENTHOL

TARGETS MULTIPLE

NERVE PAIN RECEPTORS

MASSAGING ROLL-ON

NET WT 2.5 OZ (70.9 g)


Structured Label Content

Use

temporarily relieves minor pain

Section 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children and pets.

Warnings

For external use only



Flammable

  • keep away from heat and open flame
Directions

Shake well before use

adults and children over 12 years:

  • apply a thin layer to affected area every 6 to 8 hours
  • do not exceed 3 applications in a 24 hour period
  • massage into painful area until thoroughly absorbed into skin

AFTER APPLYING, WASH HANDS WITH SOAP AND WAT ER

children 12 years or younger: ask a doctor

Store at no greater than 25°C (77°F).

Do Not Use (Do not use)

• If you have had an allergic reaction to lidocaine or other local anesthetics



• on large areas of the body or on cut, irritated, blistered, or swollen skin



• on puncture wounds



• for more than one week without consulting a doctor

Questions?

1-855-446-4345

Active Ingredients (Active ingredients)

Lidocaine HCl 4%

Menthol 1%

Inactive Ingredients (Inactive ingredients)

alcohol, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, carbomer homopolymer, ceteth-20 phosphate, cetearyl alcohol, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexyl glycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, polysorbate 60, sorbitan isostearate, steareth-2, steareth-21, tocopherol, water

When Using This Product (When using this product)

• use only as directed. Read and follow all directions and warnings on this carton.



• avoid contact with eyes and mucous membranes



• rare cases of serious burns have been reported with products of this type



• do not apply to wounds or damaged, broken or irritated skin



• do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use



• a transient burning sensation may occur upon application but generally disappears in several days



• avoid applying into skin folds

Active Ingredients Purpose (Active ingredients Purpose)

Topical anesthetic

Topical analgesic

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• condition worsens

• severe burning sensation, redness, rash or irritation develops

• symptoms persist for more than 7 days or clear up and occur again within a few days

• you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Principal Display Panel 2.5 Oz (PRINCIPAL DISPLAY PANEL - 2.5 OZ)

NERVIVE™

PAIN RELIEVING

LIQUID ROLL-ON

LIDOCAINE HCl & MENTHOL

TARGETS MULTIPLE

NERVE PAIN RECEPTORS

MASSAGING ROLL-ON

NET WT 2.5 OZ (70.9 g)


Advanced Ingredient Data


Raw Label Data

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