CALAHIST- calamine and pramoxine hydrochloride lotion

calahist by

Drug Labeling and Warnings

calahist by is a Otc medication manufactured, distributed, or labeled by WALGREEN COMPANY, BIONPHARMA INC., Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Calamine 8%

Pramoxine HCI 1%

Purpose

Skin protectant

External analgesic

Uses

■ Dries the oozing and weeping of poison:
■ ivy ■ oak ■ sumac
■ For the temporary relief of pain and itching associated with
■ minor skin irritations ■ rashes due to poison ivy, poison oak, or poison sumac
■ minor burns ■ sunburn ■ minor cuts ■ scrapes ■ insect bites

Warnings

■ For external use only ■ Use only as directed.

When using this product

do not get into eyes

Stop use and ask a doctor if

condition worsens, or if symptoms persist for 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

■ shake well before using ■ cleanse the skin with soap and water ■ let dry before each use ■ apply lotion to the affected area using cotton or soft cloth

• adults and children 2 years and older: Not more than 3 to 4 times daily as needed for comfort
• children under 2 years: Consult a doctor before use

Other information

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

Inactive ingredients

SD alcohol 38B 2.5%, camphor, diazolidinyl urea, fragrances, glycerin, hydroxypropyl methylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben and purified water

Questions or comments?

1-888-235-2466

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED walgreens.com ©2023 Walgreen Co.

Walgreens Pharmacist Recommended. Our pharmacists recommend the Walgreens brand.
We invite you to compare to national brands.
††This product is not manufactured or distributed by Bausch Health US, distributor of Caladryl® Lotion.

L0000729

R0723

PRINCIPAL DISPLAY PANEL

NDC: 0363-9411-97

Walgreens

Compare to the active ingredients
in Caladryl® Lotion ††

Calahist

MEDICATED CALAMINE LOTION /
EXTERNAL ANALGESIC /
SKIN PROTECTANT

Itch Relief

Drying action plus itch relief

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

CALAHIST 
calamine and pramoxine hydrochloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-9411
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 OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	80 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-9411-97	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/16/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	10/16/2023

Labeler - WALGREEN COMPANY (008965063)

Registrant - BIONPHARMA INC. (079637826)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	manufacture(0363-9411)