COOLING ITCH RELIEF spray

Cooling Itch Relief by

Drug Labeling and Warnings

Cooling Itch Relief by is a Otc medication manufactured, distributed, or labeled by NeilMed Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTC Active Ingredient Section

Hydrocortisone 1% Anti itch

Principal Display Panel Anti Itch Spray.jpg

USES

Temporarily relieves itching associated with minorskin irritation and rashes due to: eczema poison ivy, oak and sumac cosmetics psoriasis soaps and detergents jewelry insect bites seborrheic dermatitis

WARNINGS

For external use only

DO NOT USE

in or near the eyes for external genital vaginal or anal itching for diaper rash: ask a doctor

WHEN USING THIS PRODUCT

Keep out of eyes. Rinse with water to remove Use only as directed. Do not puncture or incinerate. Contents under pressure Do not store at temperature above 120F

STOP USE AND ASK A DOCTOR IF

condition worsens or does not improve withing 7 days symptomspersist more than 7 days or clear up and occur again within a few days

KEEP OUT OF REACH OF THE CHILDREN

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

INACTIVE INGREDIENT

Citric Acid, Disodium EDTA, Glycerin, Poloxamer 407, Polysorbate 20, SD Alcohol 40-B, Water

Dosage and Administration

See Attached Image File Principal Display Panel Anti Itch Spray

Indication & Usage

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

OTC - Keep Out of Reach of Children

Keep out of reach of the children

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

Anti-Itch Spray

INGREDIENTS AND APPEARANCE

COOLING ITCH RELIEF 
cooling itch relief spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13709-310
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13709-310-01	85 g in 1 CAN; Type 0: Not a Combination Product	11/08/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/08/2018

Labeler - NeilMed Pharmaceuticals, Inc (799295915)