e304569e-575f-498c-bc65-c9336a0bd6ea
e304569e-575f-498c-bc65-c9336a0bd6ea
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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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Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:56:55.013595 · Updated: 2026-03-14T22:55:42.107827