Lucky Hc Cream 1

Lucky Hc Cream 1
SPL v1
SPL
SPL Set ID b6e1e00d-674c-243f-e053-2a95a90a03f2
Route
TOPICAL
Published
Effective Date 2015-02-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Aloe Vera Leaf Aluminum Sulfate Yellow Wax Calcium Acetate Cetostearyl Alcohol Icodextrin Glycerin Maltodextrin Methylparaben Mineral Oil Petrolatum Propylparaben Sodium Cetostearyl Sulfate Sodium Lauryl Sulfate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-01-31

Description

Hydrocortisone 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1%

Uses

■ temporarily relieves itching associated with minor skin irritations and rashes due to: ■ eczema ■ psoriasis ■ poison ivy, oak, sumac ■ insect bites ■ detergents ■ jewelry ■ cosmetics ■ soaps ■ seborrheic dermatitis ■ temporarily relieves external anal and genital itching ■ other uses of this product should be under the advice and supervision of a doctor

Warnings

For external use only

Directions

for itching of skin irritation, inflammation and rashes: ■ adults and children 2 years of age and older: apply to affected

area not more than 3 to 4 times daily ■ children under 2 years of age: ask a doctor

for external anal and genital itching, adults: ■ when practical, clean the affected area with mild soap and water and rinse thoroughly ■ gently dry by patting or blotting with toilet tissue or a soft cloth before applying ■ apply to affected area not more than 3 to 4 times daily ■ children under 12 years of age: ask a doctor

Do Not Use

■ in the genital area if you have vaginal discharge. Consult a doctor ■ for the treatment of diaper rash. Consult a doctor

Package Label

Active Ingredient

Hydrocortisone 1%

Other Information

do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

Inactive Ingredients

aloe barbadensis leaf juice, aluminum sulfate, beeswax, calcium acetate, cetearyl alcohol, dextrin, glycerin, maltodextrin, methylparaben, mineral oil, petrolatum, propylparaben, sodium cetearyl sulfate, sodium lauryl sulfate, water

When Using This Product

■ avoid contact with eyes ■ do not use more than directed unless told to do so by a doctor ■ do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop Use and Ask A Doctor If

■ the condition worsens, symptoms persist for more than 7 days or clear up and occur again wihin a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor ■ rectal bleed occurs

Keep Out of Reach of Children

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


Structured Label Content

Uses

■ temporarily relieves itching associated with minor skin irritations and rashes due to: ■ eczema ■ psoriasis ■ poison ivy, oak, sumac ■ insect bites ■ detergents ■ jewelry ■ cosmetics ■ soaps ■ seborrheic dermatitis ■ temporarily relieves external anal and genital itching ■ other uses of this product should be under the advice and supervision of a doctor

Purpose

Anti-itch

Warnings

For external use only

Directions

for itching of skin irritation, inflammation and rashes: ■ adults and children 2 years of age and older: apply to affected

area not more than 3 to 4 times daily ■ children under 2 years of age: ask a doctor

for external anal and genital itching, adults: ■ when practical, clean the affected area with mild soap and water and rinse thoroughly ■ gently dry by patting or blotting with toilet tissue or a soft cloth before applying ■ apply to affected area not more than 3 to 4 times daily ■ children under 12 years of age: ask a doctor

Do Not Use (Do not use)

■ in the genital area if you have vaginal discharge. Consult a doctor ■ for the treatment of diaper rash. Consult a doctor

Package Label

Active Ingredient

Hydrocortisone 1%

Other Information (Other information)

do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, aluminum sulfate, beeswax, calcium acetate, cetearyl alcohol, dextrin, glycerin, maltodextrin, methylparaben, mineral oil, petrolatum, propylparaben, sodium cetearyl sulfate, sodium lauryl sulfate, water

When Using This Product (When using this product)

■ avoid contact with eyes ■ do not use more than directed unless told to do so by a doctor ■ do not put directly 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)

■ the condition worsens, symptoms persist for more than 7 days or clear up and occur again wihin a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor ■ rectal bleed occurs

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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