SEACALM SKIN ITCH RELIEF INSTANT COOLING- hydrocortisone 1% spray

SeaCalm Skin Itch Relief Instant Cooling by

Drug Labeling and Warnings

SeaCalm Skin Itch Relief Instant Cooling by is a Otc medication manufactured, distributed, or labeled by GUTHY-RENKER, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient Purpose

Hydrocortisone - 1.00% Anti-itch spray

Purpose

Anti-itch spray

Uses

Temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to eczema and psoriasis. Other uses of this product should be only under advice and supervision of a doctor.

WARNINGS

Warnings

For external use only.

Keep out of reach of the children

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

Directions

Adults and children 2 years of age and older:

For intensive relief, spray affected areas, using a clean fingertip to evenly distribute for complete coverage. Give spray 30 to 60 seconds to absorb and dry, rubbing in as needed. Use up to 3 times a day for a maximum of 7 consecutive days. If you begin a 7-day cycle, wait 23 days before starting a new cycle. Once spray has dried, apply Daily Restore Moisture-Lock Body Cream on both affected and non-affected areas as needed.

Children under 2 years of age: Do not use.

Consult a doctor.

Inactive ingredients

WATER, BUTYLENE GLYCOL, 1,2-HEXANEDIOL, PROPANEDIOL, HEPTYL GLUCOSIDE, MENTHOXYPROPANEDIOL, FUCUS VESICULOSUS EXTRACT, AVENA SATIVA (OAT) KERNEL EXTRACT, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, CRAMBE MARITIMA LEAF EXTRACT, NIACINAMIDE, BISABOLOL, SODIUM PHYTATE, GLYCERIN, CITRIC ACID, SODIUM CITRATE, BENZYL ALCOHOL, POTASSIUM SORBATE.

When using this product

• Avoid contact with the eyes
• Do not exceed the recommended daily dosage unless directed by a doctor
• Do not use any other hydrocortisone product unless you have consulted a doctor.
  

Questions or comments?

Call 888-221-6440 or visit www.seacalmskin.com

Stop use and ask a doctor if

• Condition worsens
• If symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.
  

Principal Display Panel - Package Label

TEMPORARY RELIEF FROM FLARE-UPS
+ SKIN IRRITATIONS
For unpredictable skin that has no time to waste. Itch Relief Instant Cooling Spray soothes skin quickly as it supports your natural defense system.

• Ethanol-free spray eliminates drying and stinging effects quickly.
• Delivers powerful relief while promoting skin health.
• Specially designed for those prone to eczema and psoriasis.
• Non greasy feel.
  

VEGAN
PARABEN + FRAGRANCE FREE
DERMATOLOGIST TESTED
CRUELTY FREE
ALCOHOL (ETHANOL) FREE

INGREDIENTS AND APPEARANCE

SEACALM SKIN ITCH RELIEF INSTANT COOLING 
hydrocortisone 1% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70605-045
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
LEVOMENOL (UNII: 24WE03BX2T)
GLYCERIN (UNII: PDC6A3C0OX)
CRAMBE MARITIMA LEAF (UNII: NO0DI2V62B)
GINGER (UNII: C5529G5JPQ)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)
PROPANEDIOL (UNII: 5965N8W85T)
HEPTYL GLUCOSIDE (UNII: BU2OC48XBR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHYTATE SODIUM (UNII: 88496G1ERL)
NIACINAMIDE (UNII: 25X51I8RD4)
FUCUS VESICULOSUS (UNII: 535G2ABX9M)
OAT KERNEL OIL (UNII: 3UVP41R77R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70605-045-66	1 in 1 CARTON	03/23/2019
1		22 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/23/2019

Labeler - GUTHY-RENKER, LLC (948861877)