FRESKARO CALAMINE PLUS- zinc oxide lotion lotion

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Calamine 8%

Pramoxine HCl 1%

PURPOSE

• Skin Protectant
• External Analgesic

INDICATIONS & USAGE

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

WARNINGS

For external use only. Use only as directed.

• Avoid contact with eyes and mucous membranes,

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days, or clear up and occur again within a few days

KEEP OUT OF REACH OF CHILDREN

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.

DOSAGE & ADMINISTRATION

Adults and children 2 years of age and older: Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.

Children under 2 years of age: do not use, consult a doctor.

Other information

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

INACTIVE INGREDIENT

SH Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hypromellose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparabaren and Purified water

Questions or Comments?

1-833-551-0932

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRESKARO CALAMINE PLUS 
zinc oxide lotion lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82645-420
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	80 mg  in 1 mL
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYPROMELLOSES (UNII: 3NXW29V3WO)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82645-420-96	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	04/15/2026

Labeler - Pharma Nobis, LLC (118564114)

Registrant - Pharma Nobis, LLC (118564114)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	analysis(82645-420) , manufacture(82645-420) , pack(82645-420) , label(82645-420)