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, BIONPHARMA INC., Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Calamine 8%,

Zinc Oxide 8%

Purpose

Skin protectant

Uses

Dries the oozing and weeping of poison:

• ivy
• oak
• sumac

Warnings

• For external use only
• Use only as directed.

When using this product

do not get into eyes

Ask a doctor before using

on children under 2 years of age.

Stop use and ask a doctor if

• condition worsens
• 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

• shake well before using
• cleanse the skin with soap and water
• let dry before each use
• apply lotion to the affected area using cotton or soft cloth

• adults and children 2 years and older: 3 to 4 times daily as needed for ; comfort
• children under 2 years: Consult a doctor before use

Other information

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

Inactive ingredients

bentonite magma, calcium hydroxide, carageenan, glycerin, microcrystalline cellulose, purified water and xanthan gum

Questions or comments?

Call 833-358-6431 Mon to Fri 9am to 7pm EST

SPL UNCLASSIFIED SECTION

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L0001217 Rev. 0126

Container label

NDC: 70677-1316-1

Foster & Thrive ®

Calamine
Lotion

Calamine 8%,
Zinc Oxide 8%

TOPICAL SUSPENSION, USP
SKIN PROTECTANT

Poison ivy, oak, & sumac
drying lotion

6 FL. OZ (177 mL)

INGREDIENTS AND APPEARANCE

CALAMINE 
calamine and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70677-1316
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
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
BENTONITE (UNII: A3N5ZCN45C)
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)
WATER (UNII: 059QF0KO0R)
CARRAGEENAN (UNII: 5C69YCD2YJ)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70677-1316-1	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	04/01/2025

Labeler - STRATEGIC SOURCING SERVICES (116956644)

Registrant - BIONPHARMA INC. (079637826)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	manufacture(70677-1316)