SUNMARK PHENOLATED CALAMINE- calamine and zinc oxide and phenol lotion 
Strategic Sourcing Services LLC

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Sunmark Phenolated Calamine Lotion USP

Drug Facts

Active Ingredient

Calamine 8%

Purpose

Skin Protectant

Active Ingredient

Zinc Oxide 8%

Purpose

Skin Protectant

Active Ingredient

Liquefied Phenol

Purpose

Topical Analgesic

Uses

Dries the oozing and weeping and temporarily pain and itching of poison ivy, poison oak, and poison sumac, or other minor skin irritations

Warnings

Ask a doctor

before using on children under 2 years of age.

When using this product. Discontinue use if condition worsen or does not improve within 7 days and consult a doctor.

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a poison Control Center immediately.

directions (Shake well before using)

Adult and children 2 years of age and older: Cleanse the skin with soap and water and let dry before each use. Apply product to the affected area using cotton or soft cloth, as often as needed for comfort.

Children under 2 years of age: Consult a doctor before use.

Other Information.

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

Inactive Ingredients.

Bentonite Magma, Calcium Hydroxide, Glycerin, Purified Water.

Principal Display Panel

Label

image description

SUNMARK PHENOLATED CALAMINE 
calamine and zinc oxide and phenol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-802
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
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL10 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:49348-802-34177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/12/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01603/25/1998
Labeler - Strategic Sourcing Services LLC (116956644)
Registrant - Pharma Nobis, LLC (118564114)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Nobis, LLC118564114analysis(49348-802) , manufacture(49348-802) , pack(49348-802) , label(49348-802)

Revised: 12/2023
Document Id: 0ce5c95c-a899-9b32-e063-6294a90a86b9
Set id: 8e68efc4-4c95-41c0-9fed-32297b1b2edc
Version: 6
Effective Time: 20231219
 
Strategic Sourcing Services LLC