CALAMINE- calamine, pramoxine hcl lotion
Topco associates LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Medicated Calamine
336.003 336AG

Active ingredients

Calamine 8%

Pramoxine 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, 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 TOPCO ASSOCIATES LLC,

ELK GROVE VILLAGE, IL 60007

TOPCO VIJa0622 QUESTIONS? 1-888-423-0139

topcare@topco.com www.topcarebrand.com

Quality Guaranteed

Visit here for more information: http://topbrnds.com/4901jm

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

principal display panel

TopCare Health

COMPARE TO CALADRYL LOTION ACTIVE INGREDIENTS*

NDC 76162-336-30

MEDICATED

Calamine Lotion

EXTERANAL ANALGESIC/SKIN PROTECTANT

For Relief from Pain & Itching Due to:

Poison Ivy, Oak & Sumac
Insect Bites
Minor Skin Irritations

6 FL OZ (177 mL)

image description

CALAMINE
calamine, pramoxine hcl lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76162-336
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	80 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76162-336-30	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/21/2009

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

Labeler - Topco associates LLC (006935977)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(76162-336)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(76162-336)

Revised: 8/2022

Document Id: f05447b7-b071-4b6f-abfa-b3736a6e52da

Set id: 15d1ae3f-509c-4e6b-8f0c-cf9265680358

Version: 3

Effective Time: 20220824

Topco associates LLC

Medicated Calamine336.003 336AG