CALAMINE- calamine and zinc oxide lotion 
Pharma Nobis, LLC

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Freskaro Calamine Lotion

Drug Facts

Active Ingredients

Calamine 8% and Zinc Oxide 8%

Uses

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

Purpose

Skin protectant

Warnings

For external use only. Use only as directed.

Avoid contact with eyes and mucous membranes.

Ask a doctor before using on chilren under 2 years of age.

Stop use and ask a doctor if

condition worsens, does not improve or if symptoms last 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 (1-800-222-1222) right away.

Directions

Adults and chidren 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry befroe each use. Apply lotion to the affected area using a cotton or soft cloth, not more than 3 to 4 times daily 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

Avicel, Bentonite Magma, Calcium Hydroxide, Glycerin, Purified Water, and Xanthan Gum

Questions

Questions or Comments? 1-833-551-0932

label

Freskaro Calamine 5-16-23

CALAMINE 
calamine and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82645-418
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 CATION - UNII:13S1S8SF37) ZINC CATION80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENTONITE (UNII: A3N5ZCN45C)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82645-418-96177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/16/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01605/16/2023
Labeler - Pharma Nobis, LLC (118564114)
Registrant - Pharma Nobis, LLC (118564114)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Nobis, LLC118564114label(82645-418) , manufacture(82645-418) , analysis(82645-418) , pack(82645-418)

Revised: 12/2023
Document Id: 0d99b79b-1d28-e1bc-e063-6294a90a5c9b
Set id: fbcfa541-beda-06de-e053-6294a90a9298
Version: 2
Effective Time: 20231228
 
Pharma Nobis, LLC