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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73921-035
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	80 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	80 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENTONITE (UNII: A3N5ZCN45C)
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73921-035-04	1 in 1 CARTON	04/01/2021	02/08/2023
1		118 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	04/01/2021	02/08/2023

Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)

Name	Address	ID/FEI	Business Operations
Establishment
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED		860186917	manufacture(73921-035)

Revised: 2/2023

Document Id: f42ac0ee-2d77-1dfb-e053-2995a90aa656

Set id: 0b5065b5-876e-4e72-be58-aa9d5d638a11

Version: 2

Effective Time: 20230208

GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED