Dch Nerve Pain Relief Roll-on

Dch Nerve Pain Relief Roll-on
SPL v2
SPL
SPL Set ID ff32cbb2-79eb-9158-e053-6394a90ac357
Route
TOPICAL
Published
Effective Date 2023-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 g)
Inactive Ingredients
Isohexadecane Ceteth-20 Phosphate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Steareth-21 Ethylhexylglycerin Glyceryl Monostearate Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Aloe Vera Leaf Aminomethylpropanol Dihexadecyl Phosphate Edetate Disodium Caprylyl Trisiloxane Methylparaben Cetostearyl Alcohol Water Alcohol C30-45 Alkyl Cetearyl Dimethicone Crosspolymer Dimethicone 200

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-30

Description

Lidocaine HCl 4%, Menthol 1%


Medication Information

Warnings and Precautions

For external use only. Flammable--keep away from fire or flame. Do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop use and ask a doctor if the condition worsens, 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.

Indications and Usage

Adults and children 12 years and older: apply to the affected area, not more than 6 to 8 hours. Do not exceed 3 applications in a 24-hour period. Massage into painful area until thoroughly absorbed into the skin. AFTER APPLYING WASH HANDS WITH SOAP AND WATER. Children under 12 years of age: ask a doctor.

Dosage and Administration

Temporarily relieves minor pain.

Description

Lidocaine HCl 4%, Menthol 1%

Section 50565-1

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Section 51727-6

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol Denat., Aloe Barbadensis Leaf Extract, 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, Methylparaben, Polysorbate 60, Steareth-21, Water.

Section 51945-4

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1

Topical Analgesic

Section 55106-9

Lidocaine HCl 4%, Menthol 1%


Structured Label Content

Indications and Usage (34067-9)

Adults and children 12 years and older: apply to the affected area, not more than 6 to 8 hours. Do not exceed 3 applications in a 24-hour period. Massage into painful area until thoroughly absorbed into the skin. AFTER APPLYING WASH HANDS WITH SOAP AND WATER. Children under 12 years of age: ask a doctor.

Dosage and Administration (34068-7)

Temporarily relieves minor pain.

Warnings and Precautions (34071-1)

For external use only. Flammable--keep away from fire or flame. Do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop use and ask a doctor if the condition worsens, 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.

Section 50565-1 (50565-1)

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol Denat., Aloe Barbadensis Leaf Extract, 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, Methylparaben, Polysorbate 60, Steareth-21, Water.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Lidocaine HCl 4%, Menthol 1%


Advanced Ingredient Data


Raw Label Data

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