Walgreens Calamine
FDA Label NDC 0363-4360

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Walgreens Calamine (NDC 0363-4360). 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 drug facts, active ingredients, purpose, use, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts


Active Ingredients

Calamine 8%

Zinc oxide 8%

Purpose

Skin protectant

Use

For the temporary relief of pain and itching associated with minor skin irritations.

Dries the weeping of poison ivy, poison oak and poison sumac.

Warnings

For external use only

Otc - When Using

When using this product do not get into eyes

Otc - Stop Use

Stop use and ask a doctor if condition worsens or does not improve within 7 days

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.

Directions

  • shake well before using
  • apply with cotton as needed

Other Information

Preserve in tight containers, and avoid exposure to excessive heat.

Inactive Ingredients

bentonite magma, calcium hydroxide, glycerin, purified water

Other

Distributed by: Walgreen Co.,

200 Wilmot Rd.,

Deerfield, IL 60015-4616

Quality Guaranteed

100% Satisfaction Guaranteed with all Walgreens Products or Your Money Back.

www.walgreens.com

Front Panel Display Walgreens Calamine Topical Suspension U.S.P. Skin Protectant 177Ml (0363-4360-10)

NDC 0363-4360-10

Walgreens

Calamine

Topical Suspension U.S.P.

Skin Protectant

Poison Ivy, Oak,

Sumac Dry Lotion

SAFETY SEALED: DO NOT USE IF INNER SEAL IS BROKEN OR MISSING

6 FL OZ (177 ml)


Calamine (Calamine)

Calamine (Calamine)

* Please review the disclaimer below.