SKIN A COOL HYDROCORTISONE ANTI-ITCH- hydrocortisone cream

SKIN A COOL Hydrocortisone Anti-Itch by

Drug Labeling and Warnings

SKIN A COOL Hydrocortisone Anti-Itch by is a Otc medication manufactured, distributed, or labeled by Ana-Cool, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

Active Ingredients:

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses:

• Temporary relief of skin itching.
• The temporary relief of itching associated with minor skin irritations and rashes.
• Other uses of this product should be only under the advise and supervision of a doctor.

Warnings:

For external use only.

Do not use for

• for the treatment of diaper rash. Consult a doctor.

When using this product

• Avoid contact with the eyes.
• Do not exceed the recommended daily dosage unless directed by a doctor.
• In case of bleeding, consult a doctor promptly. 
• Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if

• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days and do not begin use of any other hydrocorstisone product unless you have consulted a doctor.

Keep out of reach of children.

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

Directions:

Apply to affected area not more than 3 to 4 times daily. Adults and children 2 years of age and older:

Do not use, consult a doctor. Children under 2 years of age:

When practical, cleanse the affected area "(selected one or both of the following: with mild soap and warm water and rinse thoroughly". or "by patting or blotting with an appropriate cleansing pad").: Adults:

consult a doctor. Children under 12 years of age:

Other Information:

Store at 20-25°C (68-77°F)

Inactive ingredients:

Aloe barbadensis (aloe vera gel) juice, aqua (deionized water), C12-15 alkyl benzoate, camellia sinensis (green tea) leaf extract, ceteareth-20, cetearyl alcohol, cetyl alcohol, ethylhexylglycerin, glycerin, glyceryl stearate, hamamelis virginiana (witch hazel) extract, helianthus annuus (sunflower) seed oil, PEG-100 stearate, petrolatum, phenoxyethanol, stearyl alcohol, tocopheryl acetate (vitamin E), zemea propanediol.

Questions?

visit: skin-a-cool.com

Package Labeling:

INGREDIENTS AND APPEARANCE

SKIN A COOL HYDROCORTISONE ANTI-ITCH 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70288-173
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PEG-100 STEARATE (UNII: YD01N1999R)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70288-173-00	56.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/01/2021

Labeler - Ana-Cool, LLC (091452072)