84214-004

84214-004
SPL v1
SPL
SPL Set ID 1d199826-1b27-b6e7-e063-6394a90a69ad
Route
TOPICAL
Published
Effective Date 2024-07-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g) Camphor (natural) (10.5 g)
Inactive Ingredients
Alcohol Caryophyllene Coconut Capsaicin Ligusticum Wallichii Whole Propylene Glycol Isopropyl Myristate Paeonia Lactiflora Whole Methyl Salicylate Green Tea Leaf Water Safflower Dimethyl Sulfoxide Prunus Persica Seed Angelica Sinensis Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-13

Description

Camphor 10.5% Lidocaine 4%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Camphor 10.5% Lidocaine 4%

Use

Temporary relief from minor aches and pains.

Stop Use

if condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur again within a few days

Warnings

For external use only.Contains coconut extract.

Questions

Call 1(888) 778-2986

Ask Doctor

if condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur again within a few days

Directions

·Adults and children 12 years of age and older:Apply to affected area not more than 3 to 4 times daily

·Children under 12 years of age:Consult physician

Do Not Use

While smoking or near heat or open flame

When Using

·avoid contact with the eyes or mucous membranes

·do not apply to wounds or damaged skin

·do not apply to irritated skin

·do not bandage

·wash hands after use with cool water

·do not use with heating pad or device

·spray product away from nose,eyes,and mouth

Active Ingredient

Camphor 10.5%

Lidocaine 4%

Inactive Ingredients

Alcohol Denat, Angelica Sinensis Extract, Beta-Caryophyllene(Clove), Chili Extract, Coconut Extract, Dimethyl Sulfoxide, Green Tea Extract,Isopropyl Myristate, Peach Kernel Extract, Ligusticum Wallichii Extract, Propylene Glycol, Red Peony Flower Extract, Safflower Extract, Water, Oil of Wintergreen.

Principal Display Panel

Keep Oot of Reach of Children

If accidentally ingested get medical help or contact a Poison Control Center immediately. Make sure to turn child safety spray lock to off position when not in use. If pregnant or breast-feeding,ask a healthcare professional before use.


Structured Label Content

Use

Temporary relief from minor aches and pains.

Purpose

Topical Anesthetic

Stop Use

if condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur again within a few days

Warnings

For external use only.Contains coconut extract.

Questions

Call 1(888) 778-2986

Ask Doctor

if condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur again within a few days

Directions

·Adults and children 12 years of age and older:Apply to affected area not more than 3 to 4 times daily

·Children under 12 years of age:Consult physician

Do Not Use (Do not use)

While smoking or near heat or open flame

When Using

·avoid contact with the eyes or mucous membranes

·do not apply to wounds or damaged skin

·do not apply to irritated skin

·do not bandage

·wash hands after use with cool water

·do not use with heating pad or device

·spray product away from nose,eyes,and mouth

Active Ingredient

Camphor 10.5%

Lidocaine 4%

Inactive Ingredients (Inactive ingredients)

Alcohol Denat, Angelica Sinensis Extract, Beta-Caryophyllene(Clove), Chili Extract, Coconut Extract, Dimethyl Sulfoxide, Green Tea Extract,Isopropyl Myristate, Peach Kernel Extract, Ligusticum Wallichii Extract, Propylene Glycol, Red Peony Flower Extract, Safflower Extract, Water, Oil of Wintergreen.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

If accidentally ingested get medical help or contact a Poison Control Center immediately. Make sure to turn child safety spray lock to off position when not in use. If pregnant or breast-feeding,ask a healthcare professional before use.


Advanced Ingredient Data


Raw Label Data

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