Walgreens Aloe Vera Cooling: Package Insert and Label Information

WALGREENS ALOE VERA COOLING- menthol gel
WALGREEN CO.

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 ingredients

Menthol 0.10%
Topical Analgesic

Uses

• temporary pain relief

• helps relieve and soothes pain from sunburn, minor burns, cuts, scrapes, skin irritations and insect bites

Warnings

For external use only

When using this product

• avoid contact with eyes.

Stop use and ask a doctor if

• condition worsens or 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 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: do not use, ask a doctor

Inactive ingredients

Water, Alcohol Denat., Propylene Glycol, Glycerin, Polysorbate 20, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Juice, Disodium EDTA, Tocopherol, Diazolidinyl Urea, Blue 1, Yellow 5.

Principal Display Panel

Mix and Match

$2.99 each

2/$5

Walgreens

ALOE

VERA

COOLING GEL

Menthol

Cools and Soothes

Naturally

Moisturizes dry and

sun damaged skin

WALGREENS ALOE VERA COOLING menthol gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-4002 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 0.1 g in 100 g

Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF FD&C BLUE NO. 1 DIAZOLIDINYL UREA EDETATE DISODIUM GLYCERIN POLYSORBATE 20 PROPYLENE GLYCOL TOCOPHEROL TROLAMINE WATER FD&C YELLOW NO. 5

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0363-4002-24 170 g in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/04/2012

Labeler — WALGREEN CO. (008965063)

Revised: 12/2012 WALGREEN CO.