Cvs Calamine Plus Lotion
FDA Label NDC 69842-420

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Calamine Plus (NDC 69842-420). 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, use, warnings, stop use and ask a doctor if, keep out of reach of children., directions, 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%

Pramoxine HCl 1%

Purpose

Skin Protectant

External Analgesic

Use

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

Warnings

For external use only. Use only as directed.

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms last for more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children.

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

Directions

  • Adults and children 2 yrs. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth not more than 3 to 4 times daily as needed for comfort.
  • Children under 2 yrs. of age: Consult a doctor.

Other Information

  • store at room temperature 15 o – 30 oC (59 o – 85 oF)

Inactive Ingredient

SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hypromellose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, and Purified Water.

Principal Display Panel

Calamine
Plus
Itch Relief
6 FL OZ (177 mL)

Principal Display Panelcalamineplusitch Relief6 Fl Oz (177 mL) (Cvs Calamine Plus 01)

Principal Display Panelcalamineplusitch Relief6 Fl Oz (177 mL) (Cvs Calamine Plus 01)

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