Calamine Phenolated Topical Suspension Lotion
FDA Label NDC 82645-921

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharma Nobis, Llc for the product Calamine Phenolated Topical Suspension (NDC 82645-921). 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, ask a doctor, keep out of reach of children., directions (shake well before using), other information., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Calamine 8%

Zinc Oxide 8%

Liquefied Phenol

Purpose

Skin Protectant

Skin Protectant

Topical Analgesic

Uses

Dries the oozing and weeping and temporarily pain and itching of poison ivy, poison oak, and poison sumac, or other minor skin irritations

Warnings

  • For external use only. Use only as directed.
  • Avoid contact with eyes and mucous membranes.
  • Do not apply to large areas of the body or in large quantities, particularly over raw or blistered areas.
  • If applied to fingers or toes do not bandage.

Ask A Doctor

before using on children under 2 years of age.

When using this product. Discontinue use if condition worsen or does not improve within 7 days and consult a doctor.

Keep Out Of Reach Of Children.

In case of accidental ingestion, seek professional assistance or contact a poison Control Center immediately.

Directions (Shake Well Before Using)

Adult and children 2 years of age and older: Cleanse the skin with soap and water and let dry before each use. Apply product to the affected area using cotton or soft cloth, as often as needed for comfort.

Children under 2 years of age: Consult a doctor before use.

Other Information.

Store at room temperature 15-30C (59-86F)

Inactive Ingredients.

Bentonite Magma, Calcium Hydroxide, Glycerin, Purified Water.

Good Neighbor Label

Image Description (L040796006 Gnp Calamine Phenolated)

Image Description (L040796006 Gnp Calamine Phenolated)

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