ANA COOL RAPID SOOTHING COOLING FORMULA- hydrocortisone cream

Ana Cool Rapid Soothing Cooling Formula by

Drug Labeling and Warnings

Ana Cool Rapid Soothing Cooling Formula 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%

Anti -itch

Uses:

• Temporarily relief of external anal itching
• Temporary relief of itching associated with minor skin irritations and rashes
• Other uses of this product should be only under the advice and supervision of a doctor

Warnings:

• ​For external use only.​

Do not use 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 do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

bleeding occurs condition worsen symptoms persist for more than 7 days  or clear up occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor

Keep out of reach of children.

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

Directions:

• Adults:​ ​​cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with tissue or soft cloth before the applicationof this product
• ​Adults and children 12 years of age and older:​ apply to the affected area not more than 3 to 4 times daily.
• ​Children under 12 years of age: ​do not use, consult a doctor

Other Information

Store at 20 - 25 °C (68-77°F)

Other Ingredients:

Aloe barbadensis (aloe vera gel) juice, aqua (deionized water), C12-15 alkyl benzoate, camellia sinensis (green tea) leaf extract, cetearcth-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.

Package Labeling:

INGREDIENTS AND APPEARANCE

ANA COOL RAPID SOOTHING COOLING FORMULA 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70288-714
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
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
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)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
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: 70288-714-01	1 in 1 BOX	11/25/2015
1		56.7 g in 1 BOTTLE; 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	11/25/2015

Labeler - Ana-Cool, LLC (091452072)