HEALTH CARE CALAMINE- calamine 8% and zinc oxide 8% lotion
Great Lakes Wholesale, Marketing and Sales 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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Health Care Calamine Lotion

Drug Facts

active Ingredients

Calamine 8%

Zinc Oxide 8%

Purpose

Skin Protectant

Uses

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

Warnings

For external use only. Use only as directed.

Avoid contat with eyes and moucous membranes.

Ask a doctor

before using on children under 6 years of age.

Stop use and ask a doctor if

Condition worsens
Symptoms last for 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 immediately.

Directions

Adults and children 6 mo. of age and older: 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, as often as needed for comfort.

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

Other information

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

Inactive Ingredients

Bentonite Magma, Calcium Hydroxide, Glycerin, and Purified Water.

Questions or Comments?

Label

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HEALTH CARE CALAMINE
calamine 8% and zinc oxide 8% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64092-413
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
BENTONITE (UNII: A3N5ZCN45C)
CALCIUM HYDRIDE (UNII: WY779SQ0XW)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64092-413-96	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/27/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/01/2008

Labeler - Great Lakes Wholesale, Marketing and Sales Inc (361925498)

Registrant - Pharma Nobis, LLC (118564114)

Name	Address	ID/FEI	Business Operations
Establishment
Pharma Nobis, LLC		118564114	manufacture(64092-413) , analysis(64092-413) , pack(64092-413) , label(64092-413)

Revised: 3/2022

Document Id: da6aa5d8-d908-6ea1-e053-2995a90a3efa

Set id: 5d8f02fb-0794-8ec2-e053-2991aa0aac63

Version: 4

Effective Time: 20220317

Great Lakes Wholesale, Marketing and Sales Inc