SKIN A COOL HYDROCORTISONE ANTI-ITCH- hydrocortisone cream 
Ana-Cool, LLC

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SKIN A COOL Hydrocortisone Anti-Itch Cream

DRUG FACTS:

Active Ingredients:

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses:

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:

Label

SKIN A COOL HYDROCORTISONE ANTI-ITCH 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70288-173
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70288-173-0056.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01703/01/2021
Labeler - Ana-Cool, LLC (091452072)

Revised: 11/2023
Document Id: 09d7675e-8ab0-ac1b-e063-6394a90a58bb
Set id: e3ea7406-e494-4038-9b28-8d0a28b4b834
Version: 2
Effective Time: 20231110
 
Ana-Cool, LLC