CALAMINE- calamine, pramoxine hcl lotion

Calamine by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients

Calamine 8%

Pramoxine HCl 1%

Purpose

Skin protectant

External analgesic

Use

• 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

• 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, benzyl alcohol, camphor, fragrance, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, phenoxyethanol, polysorbate 80, propylene glycol, Rosmarinus officinalis (rosemary) leaf oil, water, xanthan gum

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Bausch Health US, LLA, distributor of Caladryl Lotion Calamine Plus Itch Reliever.

Distributed by UNFI

PROVIDENCE, RI 02908 USA

855-423-2630

Principal display panel

Compare to Caladryl Lotion active ingredient*

ndc 41163-536-30

EQUALINE

medicated calamine lotion

external analgesic

skin protectant

drying action plus itch relief

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

CALAMINE 
calamine, pramoxine hcl lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41163-536
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)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ROSEMARY OIL (UNII: 8LGU7VM393)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41163-536-30	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 Drug	M016	05/21/2009

Labeler - United Natural Foods, Inc. dba UNFI (943556183)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091520	manufacture(41163-536)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(41163-536)