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Clear Anti Itch by TOPCO ASSOCIATES

Dosage form: lotion
Ingredients: PRAMOXINE HYDROCHLORIDE 10mg in 1mL, ZINC ACETATE 1mg in 1mL
Labeler: TOPCO ASSOCIATES
NDC Code: 36800-218

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.

Clear Anti-Itch Lotion

Active Ingredients

Pramoxine HCl 1%

Zinc acetate 0.1%

Purpose

External analgesic

Skin protectant

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 if
  • condition worsens
  • symptoms last more than 7 days or clear 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 - ask a doctor

Other information

store at room temperature (59°-77°F)

Inactive ingredients

alcohol, camphor, citric acid, diazolidinyl urea, fragrance, glycerin, hydroxypropyl metyhlcellulose, methylparaben, oil of lavender, oil of rosemary, polysorbate 40, propylene glycol, propylparaben, purified water, sodium citrate

DISTRIBUTED BY TOPCO ASSOCIATES LLC

150 NORTHWEST POINT BLVE

ELK GROVE VILLAGE, IL60007

1-888-423-0139

topcare@topco.com

Principal display panel

TOPCARE

NDC 36800-218-30

Clear Anti-Itch Lotion

EXTERNAL ANALGESIC

SKIN PROTECTANT

FOR RELIEF FROM PAIN AND ITCHING DUE TO: POISON IVY - POISON SUMAC - INSECT BITES- POISON OAK AND MINOR SKIN IRRITATIONS

6 FL OZ (177 mL)

218.001/218AE

CLEAR ANTI ITCH 
pramoxine hcl, zinc acetate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-218
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
ZINC ACETATE (ZINC CATION) ZINC CATION1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
CAMPHOR (NATURAL) 
CITRIC ACID MONOHYDRATE 
DIAZOLIDINYL UREA 
GLYCERIN 
HYPROMELLOSES 
METHYLPARABEN 
LAVENDER OIL 
ROSEMARY OIL 
POLYSORBATE 40 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SODIUM CITRATE 
Packaging
#Item CodePackage Description
1NDC:36800-218-30177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/03/2009
Labeler - TOPCO ASSOCIATES (006935977)
Registrant - Vi-Jon Inc (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon, Inc790752542manufacture(36800-218)

 
TOPCO ASSOCIATES

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Medically reviewed on Oct 10, 2017

Further information

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

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