Lidocream®

Lidocream®
SPL v1
SPL
SPL Set ID a959bdfe-971e-4a14-af7d-cf366e65a1fb
Route
TOPICAL
Published
Effective Date 2022-03-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Allantoin Arnica Montana Flower Astaxanthin Benzyl Alcohol Bergamot Oil Butylated Hydroxytoluene C13-14 Isoparaffin Carbomer Interpolymer Type B (allyl Pentaerythritol Crosslinked) Cetostearyl Alcohol Cyclomethicone Diethylene Glycol Monoethyl Ether Dimethicone Dimethicone 200 Dimethyl Sulfone Edetate Sodium Emu Oil Glycerin Glyceryl Stearate Se Indian Frankincense Isopropyl Palmitate Laureth-7 Levomenol N-acetyl-glucosamine Thiazoline Peg-100 Stearate Phenoxyethanol Polyacrylamide (10000 Mw) Polyquaternium-10 (400 Mpa.s At 2%) Potassium Sorbate Propylene Glycol Salicylic Acid Sodium Hydroxide Stearic Acid Tea Tree Oil Tocopherol Trolamine Turmeric Oil Vaccinium Myrtillus Anthocyanosides Vitamin A Palmitate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-03-01

Description

Lidocaine Hydrochloride 4%

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Lidocaine Hydrochloride 4%

Use

• For the temporary relief of pain

Section 42229-5

ADVANCING PAIN RELIEF ®

INFUSED WITH Soothing Botanicals

4% Lidocaine Maximum Strength

TOPICAL ANALGESIC

pain relief cream

AEC Consumer Products

Made in the U.S.A.

Manufactured Exclusively for AEC Consumer Products

135 Airport Road, Fayetteville, NC 28306

www.shoplidocream.com

Section 50565-1

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

Warnings

For external use only

Do not use:  • in large quantities, particularly over raw or blistered surfaces  • for more than one week without consulting a doctor

When using this product: • use only as directed  • avoid contact with the eyes  • do not bandage or apply local heat (such as heating pads) to the area of use

Stop use and ask a doctor if: • condition worsens  • symptoms persist more than 7 days  • symptoms clear up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use.

Packaging

Directions

• Adults and children over 12 years: Apply as needed to affected areas 3-4 times a day. Consult a physician if pain persists.  • Children 12 years of younger: consult a doctor

Drug Facts

Questions?

1-888-AEC-3344 (1-888-232-3344)

Active Ingredient

Lidocaine Hydrochloride 4%

Inactive Ingredients

Allantoin, Arnica Montana Flower, Astaxanthin, Benzyl Alcohol, Bergamot Oil, Butylated Hydroxytoluene, C13-14 Isoparaffin, Carbomer, Cetostearyl Alcohol, Cyclomethicone, Diethylene Glycol Monoethyl Ether, Dimethicone, Dimethiconol, Dimethyl Sulfone, Edetate Sodium, Emu Oil, Glycerin, Glyceryl Stearate Se, Indian Frankincense, Isopropyl Palmitate, Laureth-7, Levomenol, N-Acetyl-Glucosamine Thiazoline, Peg-100 Stearate, Phenoxyethanol, Polyacrylamide, Polyquaternium-10, Potassium Sorbate, Propylene Glycol, Salicylic Acid, Sodium Hydroxide, Stearic Acid, Tea Tree Oil, Tocopherol, Trolamine, Turmeric Oil, Vaccinium Myrtillus Anthocyanosides, Vitamin A Palmitate, Water


Structured Label Content

Use

• For the temporary relief of pain

Section 42229-5 (42229-5)

ADVANCING PAIN RELIEF ®

INFUSED WITH Soothing Botanicals

4% Lidocaine Maximum Strength

TOPICAL ANALGESIC

pain relief cream

AEC Consumer Products

Made in the U.S.A.

Manufactured Exclusively for AEC Consumer Products

135 Airport Road, Fayetteville, NC 28306

www.shoplidocream.com

Section 50565-1 (50565-1)

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

Purpose

External Analgesic

Warnings

For external use only

Do not use:  • in large quantities, particularly over raw or blistered surfaces  • for more than one week without consulting a doctor

When using this product: • use only as directed  • avoid contact with the eyes  • do not bandage or apply local heat (such as heating pads) to the area of use

Stop use and ask a doctor if: • condition worsens  • symptoms persist more than 7 days  • symptoms clear up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use.

Packaging

Directions

• Adults and children over 12 years: Apply as needed to affected areas 3-4 times a day. Consult a physician if pain persists.  • Children 12 years of younger: consult a doctor

Drug Facts

Questions?

1-888-AEC-3344 (1-888-232-3344)

Active Ingredient

Lidocaine Hydrochloride 4%

Inactive Ingredients

Allantoin, Arnica Montana Flower, Astaxanthin, Benzyl Alcohol, Bergamot Oil, Butylated Hydroxytoluene, C13-14 Isoparaffin, Carbomer, Cetostearyl Alcohol, Cyclomethicone, Diethylene Glycol Monoethyl Ether, Dimethicone, Dimethiconol, Dimethyl Sulfone, Edetate Sodium, Emu Oil, Glycerin, Glyceryl Stearate Se, Indian Frankincense, Isopropyl Palmitate, Laureth-7, Levomenol, N-Acetyl-Glucosamine Thiazoline, Peg-100 Stearate, Phenoxyethanol, Polyacrylamide, Polyquaternium-10, Potassium Sorbate, Propylene Glycol, Salicylic Acid, Sodium Hydroxide, Stearic Acid, Tea Tree Oil, Tocopherol, Trolamine, Turmeric Oil, Vaccinium Myrtillus Anthocyanosides, Vitamin A Palmitate, Water


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)