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Calamine by Topco associates LLC

Dosage form: lotion
Ingredients: FERRIC OXIDE RED 8.6mg in 1mL, zinc oxide 20mg in 1mL, PRAMOXINE HYDROCHLORIDE 10mg in 1mL
Labeler: Topco associates LLC
NDC Code: 36800-336

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.

Drug Facts

Active ingredients

Calamine 8%

Pramoxind 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, camphor, diazolidinyl urea, fragrance, hydroxypropyl methylcellulose, methylparaben, oil of lavender, oil of rosemary, polysorbate 80, propylene glycol, propylparaben, purified water, xanthan gum

Dislcaimer

This product is not manufactured or distributed by Pfizer Consumer HealthCare, distributor of Caladryl Lotion

Adverse reactions

DIST. BY TOPCO ASSOCIATES LLC

77111 GROSS POINT RD.

SKOKIE, IL 60077

@TOPCO

QUESTIONS? 1-888-423-0139

topcare@topco.com

336.002/336AF

principal display panel

TOPCARE

NDC 36800-336-30

MEDICATED

Calamine Lotion

EXTERNAL ANALGESIC

SKIN PROTECTANT

DRING ACTION

PLUS ITCH RELIEF

For Relief From Pain And Itching Due To:

Poison Ivy, Poison Sumac, Insect Bites, Poison Oak & Minor Skin Irritations

Compare to Caladryl Lotion Active Ingredients

6 FL. OZ. (177 mL)

CALAMINE 
calamine, pramoxind hcl lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-336
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC OXIDE RED (FERRIC OXIDE RED) FERRIC OXIDE RED8.6 mg  in 1 mL
zinc oxide (zinc oxide) zinc oxide20 mg  in 1 mL
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
CAMPHOR (NATURAL) 
DIAZOLIDINYL UREA 
HYPROMELLOSES 
METHYLPARABEN 
LAVENDER OIL 
ROSEMARY OIL 
POLYSORBATE 80 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:36800-336-30177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/21/2009
Labeler - Topco associates LLC (006935977)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(36800-336)

 
Topco associates LLC

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Medically reviewed on Jul 5, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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