73647-042-04

73647-042-04
SPL v6
SPL
SPL Set ID f9aff6e7-5702-f61c-e053-6294a90aa66f
Route
TOPICAL
Published
Effective Date 2024-09-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Edetate Disodium Anhydrous Glycerin Caprylyl Glycol Phenoxyethanol Glyceryl Stearate/peg-100 Stearate Sodium Lauryl Sulfate Glycol Stearate Water Stearyl Alcohol Hexylene Glycol Cannabidiol Medium-chain Triglycerides Trideceth-6 Peg/ppg-18/18 Dimethicone Dimethicone 350 Cyclomethicone 5 Sodium Polyacrylate (8000 Mw)

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-04-26 Until 2027-10-30

Description

Lidocaine HCl 4%


Medication Information

Warnings and Precautions

For external use only.

Description

Lidocaine HCl 4%

Uses:

For the temporary relief of pain.

Section 50565-1

If swallowed, get medical help, or contact a Poison Control Center right away.

Section 50566-9

• Redness is present. • Condition worsens. • Irritation develops. • Symptoms persist for more than 7 days or clear up and occur again within a few days. • You experience signs of injury, such as pain, swelling or blistering where the product was applied.

Section 50567-7

• Use only as directed. • Avoid contact with the eyes. • Do not use in large quantities, particularly over raw surfaces, or blistered areas.

Section 51727-6

Water (Aqua), Stearyl Alcohol, Caprylic/Capric Triglyceride, Glycol Stearate, Glyceryl Stearate, PEG-100 Stearate, Sodium Lauryl Sulfate, Glycerin, Dimethicone, Sodium Polyacrylate, Cyclopentasiloxane, Trideceth-6, PEG/PPG-18/18 Dimethicone, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol, Cannabidiol, Disodium EDTA.

Section 53414-9

Ask a health professional before use.

Section 55105-1

Topical Analgesic

Section 55106-9

Lidocaine HCl 4%

Section 60561-8

Store tightly closed in a dry place at controlled room temperature between 59ºF - 86ºF (15 ºC - 30º C).

This product is intended only for use by healthy adults aged 21 years & older.

Directions

Adults over 21 years:

• Apply a small amount on the affected area.• Massage in circular motion, let set for a few seconds.• Repeat as necessary, but no more than 3 to 4 times daily

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Structured Label Content

Uses: (USES:)

For the temporary relief of pain.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

If swallowed, get medical help, or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

• Redness is present. • Condition worsens. • Irritation develops. • Symptoms persist for more than 7 days or clear up and occur again within a few days. • You experience signs of injury, such as pain, swelling or blistering where the product was applied.

Section 50567-7 (50567-7)

• Use only as directed. • Avoid contact with the eyes. • Do not use in large quantities, particularly over raw surfaces, or blistered areas.

Section 51727-6 (51727-6)

Water (Aqua), Stearyl Alcohol, Caprylic/Capric Triglyceride, Glycol Stearate, Glyceryl Stearate, PEG-100 Stearate, Sodium Lauryl Sulfate, Glycerin, Dimethicone, Sodium Polyacrylate, Cyclopentasiloxane, Trideceth-6, PEG/PPG-18/18 Dimethicone, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol, Cannabidiol, Disodium EDTA.

Section 53414-9 (53414-9)

Ask a health professional before use.

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Lidocaine HCl 4%

Section 60561-8 (60561-8)

Store tightly closed in a dry place at controlled room temperature between 59ºF - 86ºF (15 ºC - 30º C).

This product is intended only for use by healthy adults aged 21 years & older.

Directions (DIRECTIONS)

Adults over 21 years:

• Apply a small amount on the affected area.• Massage in circular motion, let set for a few seconds.• Repeat as necessary, but no more than 3 to 4 times daily

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Just Cbd Relief Soothing Cream 8 Oz (JUST CBD - RELIEF SOOTHING CREAM 8 oz)

Just Cbd Relief Soothing Cream 16 Oz (JUST CBD - RELIEF SOOTHING CREAM 16 oz)


Advanced Ingredient Data


Raw Label Data

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