Core Values 336.003/336AG Calamine Lotion

Drug Details [pdf]

CALAMINE- calamine, pramoxine hcl lotion
Liberty Procurement, Inc

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Core Values 336.003/336AG
Calamine Lotion

Active ingredients

Calamine 8%

Pramoxine HCl 1%

Purpose

Skin protectant

External analgesic

Uses

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

Distributed by

Liberty Procurement, Inc.

650 Liberty Ave.

Union, NJ 07083 USA

Visit us at: www.facevalues.com

SATISFACTION GUARANTEED

Or Your Money Back

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

principal display panel

CORE VALUES

MEDICATED

Calamine Itch Relief Lotion

EXTERNAL ANALGESIC

SKIN PROTECTANT

Drying action PLUS itch relief

6 FL OZ (177 mL)

image description

CALAMINE
calamine, pramoxine hcl lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63940-436
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 63940-436-30	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/08/2016	08/23/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	09/08/2016	08/23/2024

Labeler - Liberty Procurement, Inc (804085293)

Registrant - Consumer Product Partners, LLC (119091520)

Name	Address	ID/FEI	Business Operations
Establishment
Consumer Product Partners, LLC		119091514	manufacture(63940-436)

Revised: 5/2025

Document Id: 35a6485c-3f2f-d53c-e063-6394a90a9487

Set id: 0cf438cd-cdaf-4fda-b001-59f53622e491

Version: 5

Effective Time: 20250521

Trademark Results [Calamine]

Mark Image Registration \| Serial	Company Trademark Application Date
CALAMINE 86788723 4972728 Live/Registered	Stepanek, Julie 2015-10-15