Walgreens Cooling: Package Insert and Label Information

WALGREENS COOLING- lidocaine hydrochloride gel
WALGREEN COMPANY

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

Lidocaine hydrochloride 0.5%

Purpose

External Analgesic

Uses

temporarily relieves pain and itching due to:

  • minor skin irritations
  • sunburn
  • minor burns
  • scrapes
  • minor cuts
  • insect bites

Warnings

  • For External Use Only

​Do not use

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

When using this product

  • avoid contact with eyes. If contact occurs, rinse with water to remove.

Stop use and ask a doctor if

  • condition gets worse
  • symptoms last more than 7 days
  • symptoms clear up and occur again in a few days

Keep out of reach of children.

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

Directions

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
  • children under 2 years of age: ask a doctor

Inactive Ingredients

aloe barbadensis leaf juice, water, isopropyl alcohol, propylene glycol, glycerin, triethanolamine, carbomer, polysorbate 80, diazolidinyl urea, menthol, disodium EDTA, yellow 5, blue 1

Label

Walgreens Cooling Gel

8 OZ (226 g)

NDC 0363-0954-80

draft label
(click image for full-size original)
WALGREENS COOLING
lidocaine hydrochloride gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0954
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
TROLAMINE
FD&C BLUE NO. 1
POLYSORBATE 80
DIAZOLIDINYL UREA
WATER
MENTHOL
FD&C YELLOW NO. 5
CARBOMER INTERPOLYMER TYPE A (55000 CPS)
PROPYLENE GLYCOL
EDETATE DISODIUM (EDETIC ACID)
ISOPROPYL ALCOHOL
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0954-80 226 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 02/10/2021
Labeler — WALGREEN COMPANY (008965063)

Revised: 02/2021 WALGREEN COMPANY

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