Medicated Calamine Lotion MF 336.003-336AG

Calamine by

Drug Labeling and Warnings

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

Drug Details [pdf]

CALAMINE- calamine, pramoxine hcl lotion 
Vi-Jon, LLC

----------

Medicated Calamine Lotion MF 336.003-336AG

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 prodct

• 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, hydroxypropyl methylcellulose, methylparaben, oil of lavender, oil of rosemary, polysorbate 80, propylene glycol, propylparaben, purified water, xanthan gum

disclaimer

This product is not manufactured or distributed by Valeant Pharmaceuticals 

distributor of Caladryl Lotion

adverse reactions section

Manufactured by: Vi-Jon, Inc., St. Louis, MO 63114

Questions or comments?  1-888-593-0593

Made in the USA

with US and foreign parts.

principal display panel

Mountain Falls

*Compare to Clean & Clear

gently exfoliates

penetrates pores to eliminate most blackheads

polyethylene bead free

oil free

Blackhead Clearing Scrub

acne medication

NET WT 5 OZ (141 g)

CALAMINE 
calamine, pramoxine hcl lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0869-0336
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 (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: 0869-0336-30	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/07/2017	06/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	03/07/2017	06/14/2020

Labeler - Vi-Jon, LLC (088520668)

Registrant - Vi-Jon, LLC (088520668)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, LLC		790752542	manufacture(0869-0336)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, LLC		088520668	manufacture(0869-0336)

Revised: 2/2024

Document Id: 10543e27-0246-5deb-e063-6294a90a6a79

34390-5

Set id: 127ada2b-a6e4-434f-9805-f2fa669d8ec3

Version: 9

Effective Time: 20240201