CALAMINE- calamine, pramoxind hcl lotion

Calamine by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients

Calamine 8%

Pramoxind HCl 1%

Purpose

Skin protectant

External analgesic

Use

• for the temporary relief of pain and itching associated with minot 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

• 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 was affected are 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

Dislcaimer

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

Adverse reactions

DIST. BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL

@TOPCO VIJA071

QUESTIONS? 1-888-423-0139

topcare@topco.coM

www.topcarebrand.com

336.002/336AF

principal display panel

TopCare

Health

COMPARE TO

CALADRYL LOTION

ACTIVE INGREDIENTS

MEDICATED

Calamine

Lotion

EXTERANAL ANALGESIC/

SKIN PROTECTANT

Drying Action Plus

Itch Relief for:

Poison Ive, Oak & Sumac

OUR PHARMACISTS RECOMMEND

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

CALAMINE 
calamine, pramoxind hcl lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-336
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	8.6 mg  in 1 mL
zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z)	zinc oxide	20 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 (NATURAL) (UNII: N20HL7Q941)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
HYPROMELLOSES (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: 36800-336-30	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/21/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/21/2009

Labeler - Topco associates LLC (006935977)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(36800-336)