HEALTH CARE CALAMINE- calamine 8% and zinc oxide 8% lotion 
Great Lakes Wholesale, Marketing and Sales Inc

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Health Care Calamine Lotion

Drug Facts

active Ingredients

Calamine 8%

Zinc Oxide 8%

Purpose

Skin Protectant

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

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?

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HEALTH CARE CALAMINE 
calamine 8% and zinc oxide 8% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-413
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION160 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENTONITE (UNII: A3N5ZCN45C)  
CALCIUM HYDRIDE (UNII: WY779SQ0XW)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64092-413-96177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/27/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01601/01/2008
Labeler - Great Lakes Wholesale, Marketing and Sales Inc (361925498)
Registrant - Pharma Nobis, LLC (118564114)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Nobis, LLC118564114manufacture(64092-413) , analysis(64092-413) , pack(64092-413) , label(64092-413)

Revised: 12/2023
Document Id: 0cf4d771-f6b1-ec8c-e063-6394a90a3551
Set id: 5d8f02fb-0794-8ec2-e053-2991aa0aac63
Version: 5
Effective Time: 20231220
 
Great Lakes Wholesale, Marketing and Sales Inc