SEACALM SKIN ITCH RELIEF INSTANT COOLING- hydrocortisone 1% spray

United States - English - NLM (National Library of Medicine)

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Active ingredient:
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Available from:
GUTHY-RENKER, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Hydrocortisone - 1.00% Anti-itch spray Anti-itch spray 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. - 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.
Authorization status:
OTC monograph not final
Authorization number:
70605-045-66

SEACALM SKIN ITCH RELIEF INSTANT COOLING- hydrocortisone 1% spray

GUTHY-RENKER, LLC

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.

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SeaCalm Skin

Itch Relief Instant Cooling Spray

Active ingredient Purpose

Hydrocortisone - 1.00% Anti-itch spray

Purpos e

Anti-itch spray

Us es

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

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

TM

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

SEACALM SKIN ITCH RELIEF INSTANT COOLING

hydrocortisone 1% spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 6 0 5-0 45

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO CO RTISO NE (UNII: WI4X0 X7BPJ) (HYDROCORTISONE - UNII:WI4X0 X7BPJ)

HYDROCORTISONE

1 g in 10 0 g

GUTHY-RENKER, LLC

Inactive Ingredients

Ingredient Name

Stre ng th

LEVO MENO L (UNII: 24WE0 3BX2T)

GLYCERIN (UNII: PDC6 A3C0 OX)

CRAMBE MARITIMA LEAF (UNII: NO0 DI2V6 2B)

GINGER (UNII: C5529 G5JPQ)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM CITRATE (UNII: 1Q73Q2JULR)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

1,2 -HEXANEDIO L (UNII: TR0 46 Y3K1G)

3 -( ( L-MENTHYL) O XY) PRO PANE-1,2 -DIO L (UNII: KD6 TZ2QICH)

PRO PANEDIO L (UNII: 59 6 5N8 W8 5T)

HEPTYL GLUCO SIDE (UNII: BU2OC48 XBR)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

PHYTATE SO DIUM (UNII: 8 8 49 6 G1ERL)

NIACINAMIDE (UNII: 25X51I8 RD4)

FUCUS VESICULO SUS (UNII: 535G2ABX9 M)

O AT KERNEL O IL (UNII: 3UVP41R77R)

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:70 6 0 5-0 45-

1 in 1 CARTON

0 3/23/20 19

1

22 g in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 3/23/20 19

Labeler -

GUT HY-RENKER, LLC (948861877)

Revised: 3/2019

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