CALAMINE- calamine and zinc oxide lotion

Calamine by

Drug Labeling and Warnings

Calamine by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services, LLC, Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Calamine 8% and Zinc Oxide 8%

Uses

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

Purpose

Skin protectant

Warnings

For external use only. Use only as directed.

Avoid contact with eyes and mucous membranes.

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

Stop use and ask a doctor if

condition worsens, does not improve or if symptoms last 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 (1-800-222-1222) right away.

Directions

Adults and chidren 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry befroe each use. Apply lotion to the affected area using a cotton or 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

Other information

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

Inactive ingredients

Avicel, Bentonite Magma, Calcium Hydroxide, Glycerin, Purified Water, and Xanthan Gum

Questions

Questions? 833-358-6431

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALAMINE 
calamine and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70677-1196
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	80 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	80 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: 70677-1196-1	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/14/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	09/14/2024

Labeler - Strategic Sourcing Services, LLC (116956644)

Registrant - Pharma Nobis, LLC (118564114)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	label(70677-1196) , manufacture(70677-1196) , analysis(70677-1196) , pack(70677-1196)