Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID c64a1d9a-6ceb-441d-bd2d-00257c7df930
Route
TOPICAL
Published
Effective Date 2013-07-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Water Propylene Glycol Glycerin Isopropyl Alcohol Trolamine Polysorbate 80 Aloe Vera Leaf Menthol Edetate Disodium Diazolidinyl Urea Fd&c Yellow No. 5 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-07-12

Description

Lidocaine HCl   0.5%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic



Description

Lidocaine HCl   0.5%

Uses
  • temporary relief of pain and itching
  • helps relieve and soothes pain from sunburn, minor burns, cuts, scrapes, skin irritations and insect bites

Warnings

For external use only

Directions
  • adults and children 2 years of age and older: apply to affected areas not more than 3 to 4 times daily
  • children under 2 years of age: do not use, ask a doctor

Do Not Use

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



Active Ingredient

Lidocaine HCl   0.5%



Inactive Ingredients

Water, Propylene Glycol, Glycerin, Isopropyl Alcohol, Triethanolamine, Polysorbate 80, Carbomer, Aloe Barbadensis Leaf Juice Powder, Menthol, Disodium EDTA, Diazolidinyl Urea, Yellow 5, Blue 1.



Principal Display Panel

meijer

Burn Relief

Aloe Vera

Pain Relieving Gel

with Lidocaine HCl

Cools Sunburn Pain

NET WT. 8 OZ. (226 g)







When Using This Product
  • avoid contact with eyes

Stop Use and Ask A Doctor If
  • condition worsens or if symptoms persist for more than 7 days.
  • symptoms clear up and occur again within a few days.

Keep Out of Reach of Children

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




Structured Label Content

Uses
  • temporary relief of pain and itching
  • helps relieve and soothes pain from sunburn, minor burns, cuts, scrapes, skin irritations and insect bites

Purpose

Topical Analgesic



Warnings

For external use only

Directions
  • adults and children 2 years of age and older: apply to affected areas not more than 3 to 4 times daily
  • children under 2 years of age: do not use, ask a doctor

Do Not Use (Do not use)

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



Active Ingredient (Active ingredient)

Lidocaine HCl   0.5%



Inactive Ingredients (Inactive ingredients)

Water, Propylene Glycol, Glycerin, Isopropyl Alcohol, Triethanolamine, Polysorbate 80, Carbomer, Aloe Barbadensis Leaf Juice Powder, Menthol, Disodium EDTA, Diazolidinyl Urea, Yellow 5, Blue 1.



Principal Display Panel

meijer

Burn Relief

Aloe Vera

Pain Relieving Gel

with Lidocaine HCl

Cools Sunburn Pain

NET WT. 8 OZ. (226 g)







When Using This Product (When using this product)
  • avoid contact with eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens or if symptoms persist for more than 7 days.
  • symptoms clear up and occur again within a few days.

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

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




Advanced Ingredient Data


Raw Label Data

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