Maximum Strength Anti-itch
FDA Label NDC 63868-782

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Quality Choice for the product Maximum Strength Anti-itch (NDC 63868-782). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient                                purpose, uses, warnings, flammable: do not use while smoking or near heat or flame, when using this product, keep out of reach of the children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient                                Purpose

Hydrocortisone - 1.00%                       Anti-itch

Uses

Temporarily relieves itching associated with minor skin irritation and rashes due to:

• eczema           • poison ivy, oak and sumac         • cosmetics

• psoriasis         • soaps and detergents                  • jewelry

• insect bites     • seborrheic dermatitis

Warnings

For external use only

Flammable: Do Not Use While Smoking Or Near Heat Or Flame

When Using This Product

Avoid contact with the eyes. If condition worsens, or if symptoms
persist for more than 7 days or clear up and occur again within a
few days, stop use of this product and do not begin use of any
other hydrocortisone product unless you have consulted a doctor.
Do not use for the treatment of diaper rash. Consult a doctor.
Do not puncture or incinerate. Contents under pressure. Do not
store at temperatures above 120˚F.F

Keep Out Of Reach Of The Children

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

Directions

• shake well
• 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

• to apply to face, spray into palm of hand and gently apply

Inactive Ingredients

Citric Acid, Disodium EDTA, Glycerin, Poloxamer 188, Polysorbate 20, SD Alcohol 40-B, Water

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