Dch Pain Relief Cream, Lidocaine Hcl 4%

Dch Pain Relief Cream, Lidocaine Hcl 4%
SPL v2
SPL
SPL Set ID 00dd70f3-ecc3-33ba-e063-6294a90a4f32
Route
TOPICAL
Published
Effective Date 2022-04-18
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 2021-08-10

Description

Lidocaine HCl 4%


Medication Information

Warnings and Precautions

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 directions on this carton, avoid contact with eyes and mucous membranes, 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, do not use at the same time as other topical analgesics, 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 the condition worsens, redness is present, 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.

Indications and Usage

Adults and children over 12 years: apply a thin layer to the affected area every 6 to 8 hours, not to exceed 3 applications in a 24-hour period. AFTER APPLYING, WASH HANDS WITH SOAP AND WATER.

Children under 12 years or younger: ask a doctor.

Dosage and Administration

Temporarily relieves minor pain.

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, 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, Methylparaben, 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 over 12 years: apply a thin layer to the affected area every 6 to 8 hours, not to exceed 3 applications in a 24-hour period. AFTER APPLYING, WASH HANDS WITH SOAP AND WATER.

Children under 12 years or younger: ask a doctor.

Dosage and Administration (34068-7)

Temporarily relieves minor pain.

Warnings and Precautions (34071-1)

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 directions on this carton, avoid contact with eyes and mucous membranes, 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, do not use at the same time as other topical analgesics, 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 the condition worsens, redness is present, 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.

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, Methylparaben, 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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