SPL v2
SPL
SPL Set ID fdb74c89-255d-ab2b-e053-6294a90a098b
Route
TOPICAL
Published
Effective Date 2023-06-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Water Laureth-7 Polyacrylamide (10000 Mw) Cyclomethicone Jojoba Oil Glyceryl Stearate Se Edetate Disodium Ethylhexylglycerin .alpha.-tocopherol Acetate, Dl- Aloe Vera Leaf Calendula Officinalis Flower Sodium Hydroxide Cetyl Alcohol Phenoxyethanol Dimethicone 350 C13-14 Isoparaffin Caprylic/capric/palmitic/stearic Triglyceride Glycerin Glyceryl Stearate/peg-100 Stearate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2023-06-19

Description

Lidocaine 5%

Purpose

Topical anesthethics

Dosage and Administration

Apply a thick and even layer on the area


Medication Information

Purpose

Topical anesthethics

Dosage and Administration

Apply a thick and even layer on the area

Description

Lidocaine 5%

Warnings

If any side effect is observed, discontinued use and consult your healthcare practicioner

Directions

Wash the specific area with soap and warm water to open pores and dry. Apply a thick and even layer of the product

Do Not Use

Do not use if allergic to Lidocaine or other local anesthetics

Indications

Temporary pain relief

Package Label

Ask Your Doctor

If any side effect is observed, discontinue use and consult your healthcare practicioner

Active Ingredients

Lidocaine 5%

Inactive Ingredients

WATER, CAPRYLIC/CAPRIC/STEARIC TRIGLYCERIDE, GLYCERIN, C13-14 ISOPARAFFIN/LAURETH-7/POLYACRYLAMIDE, CYCLOMETHICONE, JOJOBA OIL, GLYCERYL STEARATE /PEG-100 STEARATE, CETYL ALCOHOL, GLYCERYL STEARATE SE, PHENOXYETHANOL & ETHYLHEXYLGLYCERIN, ALPHA TOCOPHEROL ACETATE, DL ALOE VERA LEAF EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, DIMETHICONE 350, EDETATE DISODIUM, SODIUM HYDROXIDE

Questions Or Comments

Call us 1-954-607-7658

Pregnancy Or Breast Feeding

Do not use if you are pregnant or breast feeding

Keep Out of the Reach of Children

Keep out of the reach of children


Structured Label Content

Purpose

Topical anesthethics

Warnings

If any side effect is observed, discontinued use and consult your healthcare practicioner

Directions

Wash the specific area with soap and warm water to open pores and dry. Apply a thick and even layer of the product

Do Not Use (Do not use)

Do not use if allergic to Lidocaine or other local anesthetics

Indications

Temporary pain relief

Package Label (Package label)

Ask Your Doctor (Ask your doctor)

If any side effect is observed, discontinue use and consult your healthcare practicioner

Active Ingredients (Active ingredients)

Lidocaine 5%

Inactive Ingredients (Inactive ingredients)

WATER, CAPRYLIC/CAPRIC/STEARIC TRIGLYCERIDE, GLYCERIN, C13-14 ISOPARAFFIN/LAURETH-7/POLYACRYLAMIDE, CYCLOMETHICONE, JOJOBA OIL, GLYCERYL STEARATE /PEG-100 STEARATE, CETYL ALCOHOL, GLYCERYL STEARATE SE, PHENOXYETHANOL & ETHYLHEXYLGLYCERIN, ALPHA TOCOPHEROL ACETATE, DL ALOE VERA LEAF EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, DIMETHICONE 350, EDETATE DISODIUM, SODIUM HYDROXIDE

Questions Or Comments (Questions or comments)

Call us 1-954-607-7658

Dosage and Administration (Dosage and administration)

Apply a thick and even layer on the area

Pregnancy Or Breast Feeding (Pregnancy or Breast feeding)

Do not use if you are pregnant or breast feeding

Keep Out of the Reach of Children (Keep out of the reach of children)

Keep out of the reach of children


Advanced Ingredient Data


Raw Label Data

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