Nervive™ Pain Relieving Cream

Nervive™ Pain Relieving Cream
SPL v4
SPL
SPL Set ID 1e8bfb1e-8f5a-d0f3-e063-6294a90a752a
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
Carbomer Interpolymer Type B (allyl Pentaerythritol Crosslinked) Sorbitan Isostearate Polysorbate 60 Tocopherol C30-45 Alkyl Cetearyl Dimethicone Crosspolymer Polyoxyl 15 Hydroxystearate Caprylyl Trisiloxane Edetate Disodium Water Dimethicone Dihexadecyl Phosphate Aminomethylpropanol Steareth-21 Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Isohexadecane Phenoxyethanol Ethylhexylglycerin Ceteth-20 Phosphate Glyceryl Monostearate Alcohol Cetostearyl Alcohol

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 44425-7

Store at no greater than 25°C (77°F).

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

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 WATER

children 12 years or younger: ask a doctor

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

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol, aminomethylpropanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl

methicone, ceteth-20 phosphate, cetostearyl alcohol, dicetyl phosphate, dimethicone, edetate disodium, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, polyoxyl 15 hydroxystearate, polysorbate 60, sorbitan isostearate, 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
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 3.0 Oz

NERVIVE™

PAIN RELIEVING CREAM

LIDOCAINE HCl & MENTHOL

TARGETS MULTIPLE

NERVE PAIN RECEPTORS

PENETRATING CREAM

MEDICATED CREAM NET WT 3.0 OZ (85.1 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 44425-7 (44425-7)

Store at no greater than 25°C (77°F).

Section 50565-1 (50565-1)

Keep out of reach of children and pets.

Purpose

Topical anesthetic

Topical analgesic

Warnings

For external use only

Flammable

  • keep away from heat and open flame
Directions

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 WATER

children 12 years or younger: ask a doctor

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)

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol, aminomethylpropanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl

methicone, ceteth-20 phosphate, cetostearyl alcohol, dicetyl phosphate, dimethicone, edetate disodium, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, polyoxyl 15 hydroxystearate, polysorbate 60, sorbitan isostearate, 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
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 3.0 Oz (PRINCIPAL DISPLAY PANEL - 3.0 OZ)

NERVIVE™

PAIN RELIEVING CREAM

LIDOCAINE HCl & MENTHOL

TARGETS MULTIPLE

NERVE PAIN RECEPTORS

PENETRATING CREAM

MEDICATED CREAM NET WT 3.0 OZ (85.1 g)


Advanced Ingredient Data


Raw Label Data

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