Dch Pain Relief Roll-on

Dch Pain Relief Roll-on
SPL v2
SPL
SPL Set ID fda35d37-f36e-efc8-e053-6294a90a2bb8
Route
TOPICAL
Published
Effective Date 2022-04-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Steareth-21 Ethylhexylglycerin Glyceryl Monostearate Ceteth-20 Phosphate Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Aloe Vera Leaf Aminomethylpropanol Dihexadecyl Phosphate Edetate Disodium Caprylyl Trisiloxane Methylparaben Cetostearyl Alcohol Water C30-45 Alkyl Cetearyl Dimethicone Crosspolymer Dimethicone 200 Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-21

Description

Lidocaine HCl 4%


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. When using this product keep out of eyes, do not apply to wounds or damaged skin, do not bandage tightly.

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.

Indications and Usage

Adults and children 12 years and older: apply to the affected area, not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

Dosage and Administration

For the temporary relief of pain and itching.

Description

Lidocaine HCl 4%

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, 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, Methylparaben, SD Alcohol 40, Steareth-21, Water.

Section 51945-4

Section 55105-1

Topical Analgesic

Section 55106-9

Lidocaine HCl 4%


Structured Label Content

Indications and Usage (34067-9)

Adults and children 12 years and older: apply to the affected area, not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

Dosage and Administration (34068-7)

For the temporary relief of pain and itching.

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. When using this product keep out of eyes, do not apply to wounds or damaged skin, do not bandage tightly.

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.

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, 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, Methylparaben, SD Alcohol 40, Steareth-21, Water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Lidocaine HCl 4%


Advanced Ingredient Data


Raw Label Data

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