Warnings
- For external use only
- Avoid contact with eyes and mucous membranes
- Ask a doctor before using on children under 2 years of age
Leader Calamine Plus Lotion
FDA Label NDC 70000-0400
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health, 110 Dba Leader for the product Leader Calamine Plus (NDC 70000-0400). 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 warnings, otc - active ingredient, otc - purpose, dosage & administration, inactive ingredient, otc - keep out of reach of children, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Calamine 8%
Pramoxine HCl 1%
Otc - Purpose
- Skin Protectant
- External Analgesic
Dosage & Administration
Adults and children 2 years of age and older: Shake well before using. CLeanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton of soft cloth, not more than 3 to 4 times daily as needed for comfort.
Children under 2 years of age: Consult a doctor before use.
Inactive Ingredient
SH Alcohol 38B 2.5%
Camphor
Diazolidinyl Urea
Fragrances
Glycerin
Hydroxypropyl Methylcellulose
Methylparaben
Polysorbate 80
Propylene Glycol
Propylparabaren
Purified water
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)
Indications & Usage
Uses:
temporarily relieves pain and itching associated with:
- rashes due to poison ivy, poison oak, or poison sumac
- insect bites
- minor skin irritation
- minor cuts
- ​dries the oozing and weeping of poison ivy, poison oak and poison sumac
Package Label.Principal Display Panel
Calamineplus (Calamineplus)
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