CALAMINE- calamine, pramoxine hcl lotion

Calamine by

Drug Labeling and Warnings

Calamine by is a Otc medication manufactured, distributed, or labeled by Walgreen CO, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Calamine 8%

Pramoxine    HCl 1%

Purpose

Skin protectant

External analgesic

Uses

• for the temporary relief of pain and itching associated with minor skin irritations and rashes due to poison ivy, poison oak, or poison sumac
• dries the oozing and weeping of poison: -ivy -oak -sumac

Warnings

For external use only

When using this product

• do not get into eyes

Stop use and ask a doctor if

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• shake well
• before applying wash affected area of skin

Adults and children 2 years of age and older - apply to affected area not more than 3 to 4 times daily

Children under 2 years of age - do not use, ask a doctor

Other information

store at room temperature (59°-77°F)

Inactive ingredients

alcohol, camphor, diazolidinyl urea, fragrance, hypromellose, methylparaben, oil of lavender, oil of rosemary, polysorbate 80, propylene glycol, propylparaben, purified water, xanthan gum

Rear label text

Distributed by:  WALGREEN CO.

200 WILMOT RD., DERRFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com  (C) 2016 Walgreen Co.

L001621SC

††This product is not manufactured or distributed by Valeant Pharmaceuticals, distributor of Caladryl Lotion.

Walgreens pharmacist recommended

Walgreens Pharmacist survey study.  November 2016.

336.002/336AF

principal display panel

Walgreens

Calahist

Medicated Calamine Lotion/External Analgesic/Skin Protectant

Drying action plus itch relief

Compare to Caladryl Lotion active ingredients ††

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

CALAMINE 
calamine, pramoxine hcl lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-9336
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	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)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
METHYLPARABEN (UNII: A2I8C7HI9T)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ROSEMARY OIL (UNII: 8LGU7VM393)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-9336-30	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/07/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/07/2017

Labeler - Walgreen CO (008965063)

Registrant - Vi-Jon, LLC (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, LLC		790752542	manufacture(0363-9336)