CALAMINE- calamine, pramoxind hcl lotion
Consumer Product Partners, LLC

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Good Sense 336.003/336AG
Medicated 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 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 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

Disclaimer

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

Adverse reaction

Distributed by Perrigo Direct, Inc.

Peachtree City, GA 30269

www.PerrigoDirect.com

1-888-593-0593

Good Sense is a registered trademark of L. Perrigo Company

Principal display panel

NDC 11344-336-30

GoodSense

MEDICATED

Calamine Itch Relief Lotion

EXTERNAL ANALGESIC/SKIN PROTECTANT

Pain and itch reliever

Compare to active ingredients of Caladryl Lotion*

6 FL OZ (177 mL)

image description

CALAMINE
calamine, pramoxind hcl lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11344-336
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:11344-336-30	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/08/2016	06/20/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	09/08/2016	06/20/2025

Labeler - Consumer Product Partners, LLC (119091520)

Registrant - Consumer Product Partners, LLC (119091520)

Name	Address	ID/FEI	Business Operations
Establishment
Consumer Product Partners, LLC		119091514	manufacture(11344-336)

Revised: 6/2025

Document Id: 38029d37-f03f-3344-e063-6394a90ad68b

Set id: 482898e5-ec45-4582-b61b-cedc1ed32a92

Version: 4

Effective Time: 20250620

Consumer Product Partners, LLC

Good Sense 336.003/336AG Medicated Calamine Lotion