e304569e-575f-498c-bc65-c9336a0bd6ea

SPL v1
SPL
SPL Set ID e304569e-575f-498c-bc65-c9336a0bd6ea
Route
topical
Published
Effective Date 2019-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydrocortisone (10 mg)
Inactive Ingredients
cetostearyl alcohol glyceryl stearate se methylchloroisothiazolinone propylene glycol water stearic acid trolamine petrolatum

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2019-11-01

Purpose

Antipruritic (Anti-itch)

Description

Drug Facts


Medication Information

Warnings

For external use only

Uses

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching

Purpose

Antipruritic (Anti-itch)

Directions
  • 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: consult a doctor
  • When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Children under 12: consult a doctor before using for anal itching
Other Information
  • Store at room temperature
  • Avoid excessive heat
Inactive Ingredients

Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine, White Soft Paraffin

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use

Do Not Use
  • In the eyes
  • For diaper rash
  • For external genital or feminine itching if you have a vaginal discharge
  • More than the recommended daily dosage unless directed by a doctor
  • This product in the rectum by using fingers or any mechanical device or applicator
Active Ingredients

Hydrocortisone USP 1%

Stop Use and Ask A Doctor If
  • Condition worsens, symptoms persist for more than 7 days, or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have asked a doctor
  • In case of bleeding when used for anal itching
Principal Display Panel 1 Oz. Tube Label

Safetec ®

1% Hydrocortisone Cream

For Itching, Inflammation, and Rashes

Net Wt. 1oz. (28.4g)

Reorder No. 53111

Manufactured for: Safetec of America, Inc.

Buffalo, NY 14215 | 1-800-456-7077

Made In India KD/503


Structured Label Content

Warnings

For external use only

Uses

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching

Purpose

Antipruritic (Anti-itch)

Directions
  • 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: consult a doctor
  • When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Children under 12: consult a doctor before using for anal itching
Other Information
  • Store at room temperature
  • Avoid excessive heat
Inactive Ingredients

Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine, White Soft Paraffin

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use

Do Not Use (Do not use)
  • In the eyes
  • For diaper rash
  • For external genital or feminine itching if you have a vaginal discharge
  • More than the recommended daily dosage unless directed by a doctor
  • This product in the rectum by using fingers or any mechanical device or applicator
Active Ingredients

Hydrocortisone USP 1%

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Condition worsens, symptoms persist for more than 7 days, or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have asked a doctor
  • In case of bleeding when used for anal itching
Principal Display Panel 1 Oz. Tube Label (Principal Display Panel - 1 oz. Tube Label)

Safetec ®

1% Hydrocortisone Cream

For Itching, Inflammation, and Rashes

Net Wt. 1oz. (28.4g)

Reorder No. 53111

Manufactured for: Safetec of America, Inc.

Buffalo, NY 14215 | 1-800-456-7077

Made In India KD/503


Advanced Ingredient Data


Raw Label Data

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