CALAMINE CLEAR- pramoxine hydrochloride and zinc acetate lotion lotion

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Pramoxine HCl 1%

Zinc Acetate 0.1%

PURPOSE

External Analgesic & Skin Protectant

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 fo 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

SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Usea, Fragrances, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, Purified Water

Questions or comments?

1-833-551-0932

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALAMINE CLEAR 
pramoxine hydrochloride and zinc acetate lotion lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82645-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 mL
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82645-400-96	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	manufacture(82645-400) , pack(82645-400) , analysis(82645-400) , label(82645-400)