Goodsense Pain Relief Roll-on

Goodsense Pain Relief Roll-on
SPL v3
SPL
SPL Set ID 38e76fd6-e5fb-493c-e063-6294a90afed4
Route
TOPICAL
Published
Effective Date 2020-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Water Glycerin Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Alcohol Aminomethyl Propanol C30-45 Alkyl Cetearyl Dimethicone Crosspolymer Aloe Vera Leaf Cetearyl Alcohol Ceteth-20 Phosphate Dicetyl Phosphate Dimethicone 200 Edetate Disodium Steareth-21 Glyceryl Stearate Methylparaben Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-04

Description

Lidocaine HCl 4%


Medication Information

Warnings and Precautions

For external use only.

Flammable. Keep away from excessive heat or open flame.

Do not use in large quantities, particularly over raw surfaces or blistered areas.

When using this product avoid contact with eyes. Rinse with water if contact occurs. Do not apply to wounds or damaged skin. Do not bandage tightly.

Stop use and ask a doctor if the condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days, and redness or irritation develops.

Indications and Usage

For the temporary relief of pain

Dosage and Administration

Adults and children 12 years and older: clean affected area before applying products, apply to affected area not more than 3 to 4 times daily.

Children under 12 years old: ask a doctor.

Description

Lidocaine HCl 4%

Section 50565-1

Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.

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, glycerin stearate, methylparaben, steareth-21, water.

Section 51945-4

Section 53414-9

Ask a health professional before use.

Section 55105-1

Topical anesthetic

Section 55106-9

Lidocaine HCl 4%


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of pain

Dosage and Administration (34068-7)

Adults and children 12 years and older: clean affected area before applying products, apply to affected area not more than 3 to 4 times daily.

Children under 12 years old: ask a doctor.

Warnings and Precautions (34071-1)

For external use only.

Flammable. Keep away from excessive heat or open flame.

Do not use in large quantities, particularly over raw surfaces or blistered areas.

When using this product avoid contact with eyes. Rinse with water if contact occurs. Do not apply to wounds or damaged skin. Do not bandage tightly.

Stop use and ask a doctor if the condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days, and redness or irritation develops.

Section 50565-1 (50565-1)

Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.

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, glycerin stearate, methylparaben, steareth-21, water.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

Ask a health professional before use.

Section 55105-1 (55105-1)

Topical anesthetic

Section 55106-9 (55106-9)

Lidocaine HCl 4%


Advanced Ingredient Data


Raw Label Data

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