Calamine Lotion
FDA Label NDC 76162-336

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Calamine (NDC 76162-336). 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 ingredients, purpose, use, warnings, when using this product, stop use and ask a doctor, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Use

→ Warnings

→ When Using This Product

→ Stop Use And Ask A Doctor

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Other

→ Principal Display Panel

Active Ingredients

Calamine 8%

Pramoxine HCl 1%

Purpose

Skin protectant

External analgesic

Use

for the temporary relief of pain and itching associated with minot skin irritations and rashes due to poison ivy, poison oak, or poison sumac
dries the oozing and weeping of poison:
ivy
oak
sumac

Warnings

For external use only

When Using This Product

do not get into eyes

Stop Use And Ask A Doctor

condition worsens
symptoms last more than 7 days or clean up and occur again within a few days

Keep Out Of Reach Of Children

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

Directions

shake well
before applying was affected are of skin

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 - do not use, ask a doctor

Other Information

store at room temperature (59°-77°F)

Inactive Ingredients

alcohol, camphor, diazolidinyl urea, fragrance, hypromellose, methylparaben, oil of lavender, oil of rosemary, polysorbate 80, propylene glycol, propylparaben, purified water, xanthan gum