CALAMINE CLEAR- pramoxine hydrochloride and zinc acetate lotion lotion

Calamine Clear by

Drug Labeling and Warnings

Calamine Clear by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, 110 dba Leader. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Pramoxine HCl 1%

Zinc Acetate 0.1%

PURPOSE

External Analgesic & Skin Protectant

INDICATIONS & USAGE

Temporarily Relieves Pain and Itching Associated with:

rashes due to poison ivy, poison oak, or poison sumac
insect bites
minor skin irritation
minor cuts
dries the oozing and weeping of poison ivy, poison oak and poison sumac

WARNINGS

For external use only. Use only as directed.

Acoid contact with eyes and mucous membranes

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)

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 dialy as needed for comfort.

INACTIVE INGREDIENT

SD Alcohol 38B 2.5%

Camphor

Diazolidinyl Usea

Fragrances

Glycerin

Hydroxypropyl Methylcellulose

Methylparaben

Polysorbate 80

Propylene Glycol

Propylparaben

Purified Water

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: 70000-0397
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
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0397-1	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/15/2019

Labeler - Cardinal Health (097537435)