Private Label Lidocaine 4% Roll-on

Private Label Lidocaine 4% Roll-on
SPL v4
SPL
SPL Set ID a8be9e46-1616-40a9-e053-2a95a90ac3bc
Route
TOPICAL
Published
Effective Date 2019-06-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Aminomethylpropanol Water Steareth-21 Alcohol Methylparaben Caprylyl Trisiloxane Carbomer Interpolymer Type A (55000 Cps) Aloe Vera Leaf Glyceryl Monostearate Ethylhexylglycerin Edetate Disodium Anhydrous Dihexadecyl Phosphate Ceteth-20 Phosphate Dimethicone Cetostearyl Alcohol Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-06-05

Description

Adults and children 2 years of age and older : apply to the affected area no more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.


Medication Information

Warnings and Precautions

For External Use Only.

When using this product:

use only as directed

do not bandage tightly or use with a heating pad

avoid contact with eyes

do not apply to wounds or damaged skin

do not use in large quantities

partifcularly over raw surfaces or blistered areas

Indications and Usage

For temporarily relief of pain and itching.

Dosage and Administration

Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily.

Children under 2 years of age: consult a doctor.

Description

Adults and children 2 years of age and older : apply to the affected area no more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 51727-6

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, 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, methylparaben, polysorbate 60, SD alcohol 40 (15%), steareth-2, steareth-21, water

Section 55105-1

Topical analgesic

Section 55106-9

Lidocaine 4%

Cvs Label

Equate Label


Structured Label Content

Indications and Usage (34067-9)

For temporarily relief of pain and itching.

Dosage and Administration (34068-7)

Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily.

Children under 2 years of age: consult a doctor.

Warnings and Precautions (34071-1)

For External Use Only.

When using this product:

use only as directed

do not bandage tightly or use with a heating pad

avoid contact with eyes

do not apply to wounds or damaged skin

do not use in large quantities

partifcularly over raw surfaces or blistered areas

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, 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, methylparaben, polysorbate 60, SD alcohol 40 (15%), steareth-2, steareth-21, water

Section 55105-1 (55105-1)

Topical analgesic

Section 55106-9 (55106-9)

Lidocaine 4%

Cvs Label (CVS Label)

Equate Label


Advanced Ingredient Data


Raw Label Data

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