Ana-cool Rapid Soothing & Cooling Formula

Ana-cool Rapid Soothing & Cooling Formula
SPL v4
SPL
SPL Set ID 64b80cc2-e2d8-4535-aaf8-c031f4159cd1
Route
TOPICAL
Published
Effective Date 2015-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Water Alkyl (c12-15) Benzoate Green Tea Leaf Cetostearyl Alcohol Cetyl Alcohol Ethylhexylglycerin Glycerin Glyceryl Monostearate Hamamelis Virginiana Top Sunflower Oil Aloe Vera Leaf Peg-100 Stearate Petrolatum Phenoxyethanol Stearyl Alcohol .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-11-25

Description

Hydrocortisone  1.0%


Medication Information

Description

Hydrocortisone  1.0%

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
Section 55105-1

Anti -itch

Warnings:
  • ​For external use only.
Directions:
  •  ​​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:​
  • ​ apply to the affected area not more than 3 to 4 times daily. ​Adults and children 12 years of age and older:
  • ​do not use, consult a doctor ​Children under 12 years of age:
Do Not Use For

the treatment of diaper rash. Consult a doctor.

Other Information

Store at 20 - 25 °C (68-77°F)

Package Labeling:

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.

Active Ingredients:

Hydrocortisone  1.0%

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


Structured Label Content

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
Section 55105-1 (55105-1)

Anti -itch

Warnings:
  • ​For external use only.
Directions:
  •  ​​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:​
  • ​ apply to the affected area not more than 3 to 4 times daily. ​Adults and children 12 years of age and older:
  • ​do not use, consult a doctor ​Children under 12 years of age:
Do Not Use For (Do not use for)

the treatment of diaper rash. Consult a doctor.

Other Information

Store at 20 - 25 °C (68-77°F)

Package Labeling:

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.

Active Ingredients:

Hydrocortisone  1.0%

When Using This Product, (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 (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. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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