Cooling Itch Relief Well At Walgreens: Package Insert and Label Information

COOLING ITCH RELIEF WELL AT WALGREENS- hydrocortisone spray
Walgreens

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 Purpose

Hydrocortisone — 1.00% Anti-itch

Uses

For the temporary relief of itching associated with minor
skin irritation and rashes due to: • eczema • poison ivy, oak and
sumac • cosmetics • jewelry • soaps and detergents • insect
bites. Other uses of this product should be only under the advice
and supervision of a doctor.

Warnings
For external use only.
Flammable: Keep away from fire or flame
Avoid contact with the eyes. If condition worsens, or if symptoms
persist for more than 7 days or clear up and occur again within a
few days, stop use of this product and do not begin use of any
other hydrocortisone product unless you have consulted a doctor.
Do not use for the treatment of diaper rash. Consult a doctor.
Do not puncture or incinerate. Contents under pressure. Do not
store at temperatures above 120˚F

Keep out of reach of the 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: do not use, consult a doctor

Inactive ingredients

Citric Acid, Disodium EDTA, Glycerin, Poloxamer 188, Polysorbate 20, SD Alcohol 40-B, Water

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COOLING ITCH RELIEF WELL AT WALGREENS
hydrocortisone 1% spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-3106
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydrocortisone (HYDROCORTISONE) Hydrocortisone 1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
Glycerin
Poloxamer 188
Polysorbate 20
ALCOHOL
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-3106-03 85 g in 1 CAN None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 03/15/2013
Labeler — Walgreens (008965063)
Registrant — Product Quest Mfg (927768135)
Establishment
Name Address ID/FEI Operations
Product Quest Mfg 927768135 manufacture (0363-3106), label (0363-3106)

Revised: 06/2018 Walgreens

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