L-Topical CALAMINE 8% ZINC OXIDE 8% LOTION

L-Topical CALAMINE 8% ZINC OXIDE 8% by

Drug Labeling and Warnings

L-Topical CALAMINE 8% ZINC OXIDE 8% by is a Otc medication manufactured, distributed, or labeled by GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

L-TOPICAL CALAMINE 8% ZINC OXIDE 8%- calamine, zinc oxide lotion 
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED

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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L-Topical CALAMINE 8% ZINC OXIDE 8% LOTION

DRUG FACTS

Active ingredient

Calamine 8% and Zinc Oxide 8%

Purpose

Skin protectant

INDICATIONS & USAGE

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 6 months of age.

KEEP OUT OF REACH OF CHILDREN
In case of accidental ingestion, seek professional assistance or contact a Poison Control center immediately.

DOSAGE & ADMINISTRATION

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.

INACTIVE INGREDIENT

Bentonite magma, Calcium hydroxide, Glycerin, Purified water.

Other information

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

Questions?

Call toll-free 1-800-572-6632, Weekdays 7:00 AM - 5.30 PM EST.

Soothing calamine lotion

Poison Ivy Poison Oak Poison Sumac

Manufactured by :

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

Calamine1

L-TOPICAL CALAMINE 8% ZINC OXIDE 8% 
calamine, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73921-035
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED80 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENTONITE (UNII: A3N5ZCN45C)  
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73921-035-041 in 1 CARTON04/01/202102/08/2023
1118 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/01/202102/08/2023
Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)
Establishment
NameAddressID/FEIBusiness Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED860186917manufacture(73921-035)

Revised: 2/2023
 

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