Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID a383efb7-92fa-49a4-a436-af3e22d54acf
Route
TOPICAL
Published
Effective Date 2011-06-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (2.8 g)
Inactive Ingredients
Aloe Vera Leaf Water Cholesterol Isopropyl Myristate Caprylic/capric Mono/diglycerides Glyceryl Monostearate Arginine Hydrochloride Propylene Glycol Ethyl Oleate Tocophersolan Cetyl Alcohol Xanthan Gum Trolamine Allantoin Alpha-tocopherol Methylisothiazolinone Methyl Nicotinate Lecithin, Soybean Medium-chain Triglycerides

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-07-23

Description

Lidocaine 5%

Purpose

Topical Anesthetic


Medication Information

Purpose
Topical Anesthetic

Description

Lidocaine 5%

Uses
■  rapid onset

■  temporary relief of pain and itching due to

■  minor burns

■  skin irritations

■  scrapes

■  cuts

■  sunburn

■  insect bites
Labels






Section 50565-1

Keep out of the reach of children.

Warnings
For external use only.

Directions
■  adults and children 2 years and up apply externally to affected areas 3-4 times a day.
Do Not Use
■  in or near eyes

■  in large quantities, particularly over raw surfaces or blistered areas

Stop Use If
■  allergic reaction occurs

■  condition worses or does not improve within 7 days

Active Ingredient

Lidocaine 5%





Inactive Ingredients

Aloe Vera Juice, Water, Cholesterol, lsopropyl Myristate, Aqua and Caprylic Capric Triglyceride and Propylene Glycol and Hydrogenated Phosphatitylcholine, Glyceryl Stearate and PEG-100 Stearate, Arginine HCI, Ethyl OLeate, Propylene Glycol, dAlpha-Tocopheryl Polyethylene Glycol-1000 Succinate, Cetyl Alcohol,  Triethanolamine, Xanthan Gum, Vitamin E, Allantoin, Aloe Vera Powder, Methylisothiazolinone, Methyl Nicotinate


Structured Label Content

Uses
■  rapid onset

■  temporary relief of pain and itching due to

■  minor burns

■  skin irritations

■  scrapes

■  cuts

■  sunburn

■  insect bites
Labels






Section 50565-1 (50565-1)

Keep out of the reach of children.

Purpose
Topical Anesthetic

Warnings
For external use only.

Directions
■  adults and children 2 years and up apply externally to affected areas 3-4 times a day.
Do Not Use
■  in or near eyes

■  in large quantities, particularly over raw surfaces or blistered areas

Stop Use If (Stop use if)
■  allergic reaction occurs

■  condition worses or does not improve within 7 days

Active Ingredient

Lidocaine 5%





Inactive Ingredients

Aloe Vera Juice, Water, Cholesterol, lsopropyl Myristate, Aqua and Caprylic Capric Triglyceride and Propylene Glycol and Hydrogenated Phosphatitylcholine, Glyceryl Stearate and PEG-100 Stearate, Arginine HCI, Ethyl OLeate, Propylene Glycol, dAlpha-Tocopheryl Polyethylene Glycol-1000 Succinate, Cetyl Alcohol,  Triethanolamine, Xanthan Gum, Vitamin E, Allantoin, Aloe Vera Powder, Methylisothiazolinone, Methyl Nicotinate


Advanced Ingredient Data


Raw Label Data

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