CALAMINE- calamine and zinc oxide lotion

Calamine by

Drug Labeling and Warnings

Calamine by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores, Inc., Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

CALAMINE- calamine 8% and zinc oxide 8% lotion Wal-Mart Stores, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Equate Calamine Lotion

Drug Facts

Active Ingredients

Calamine 8% and Zinc Oxide 8%

Purpose

Skin protectant

Uses

dries the oozing and weeping of poison ivy, poison oak, and poison sumac.

Warnings

For external use only. Use only as directed. Avoid contact with eyes and mucous membranes.

Ask a doctor before using on children under 2 years of age.

When using this product

Discontinue use if condition worsens 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

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

Children under 6 months of age: Consult a doctor before use.

Other information

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

Inactive ingredients

Avicel, Bentonite magma, Calcium Hydroxide, Carrageenan, Glycerin, Purified Water, and Xanthan Gum.

Label

PRINCIPAL DISPLAY PANEL

NDC: 49035-413-96
equate
Calamine
LOTION
(Calamine topical
suspension, USP)
6 FL OZ (177mL)

Revised: 12/2017       Wal-Mart Stores, Inc.

INGREDIENTS AND APPEARANCE

CALAMINE 
calamine and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-413
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	160 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENTONITE (UNII: A3N5ZCN45C)
CARRAGEENAN (UNII: 5C69YCD2YJ)
XANTHAN GUM (UNII: TTV12P4NEE)
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-413-96	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/30/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	12/30/2017

Labeler - Wal-mart Stores, Inc. (051957769)