drug facts

drug facts
SPL v2
SPL
SPL Set ID 36951b55-c8bb-4100-98e3-9a39fdcb76ea
Route
topical
Published
Effective Date 2016-03-23
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, unspecified form edetate disodium diazolidinyl urea fd&c yellow no. 5 fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2015-07-08

Purpose

Topical Analgesic

Description

Lidocaine HCl 0.5%


Medication Information

Warnings

For external use only

Uses
  • Temporarily relieves pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites, or minor skin irritations.

Purpose

Topical Analgesic



Directions
  • adults and children 2 years and older:apply to affected areas as needed, not more than 3 to 4 times a day
  • children under 2 years:ask a doctor before use

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.

Description

Lidocaine HCl 0.5%

Principal Display Panel

CVS pharmacy

Compare to Solarcaine

Burn Relief Gel

NEW!

BURN RELIEF GEL

WITH LIDOCAINE HCl

RESTORES MOISTURE



  • Soothes and relieves
  • Cooling sunburn relief
  • Topical analgesic gel


NET WT 8 OZ (226 g)















Do Not Use

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



Active Ingredient

Lidocaine HCl 0.5%



Questions Or Comments?

Call toll free 1-800-SHOP CVS

When Using This Product
  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop Use and Ask A Doctor If
  • irritation or rash develops
  • condition worsens or symptoms persist for more than 7 days or 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

Warnings

For external use only

Uses
  • Temporarily relieves pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites, or minor skin irritations.

Purpose

Topical Analgesic



Directions
  • adults and children 2 years and older:apply to affected areas as needed, not more than 3 to 4 times a day
  • children under 2 years:ask a doctor before use

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

CVS pharmacy

Compare to Solarcaine

Burn Relief Gel

NEW!

BURN RELIEF GEL

WITH LIDOCAINE HCl

RESTORES MOISTURE



  • Soothes and relieves
  • Cooling sunburn relief
  • Topical analgesic gel


NET WT 8 OZ (226 g)















Do Not Use (Do not use)

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



Active Ingredient (Active ingredient)

Lidocaine HCl 0.5%



Questions Or Comments? (Questions or comments?)

Call toll free 1-800-SHOP CVS

When Using This Product (When using this product)
  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation or rash develops
  • condition worsens or symptoms persist for more than 7 days or 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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