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Clear Anti-Itch by Foodhold U.S.A. LLC

Dosage form: lotion
Ingredients: PRAMOXINE HYDROCHLORIDE 1mg in 1mL, ZINC ACETATE 0.1mg in 1mL
Labeler: Foodhold U.S.A. LLC
NDC Code: 41520-218

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

Uses
  • for the temporary relief of pain and itching associated with monor sking irritations and rashed due to poison ivy, poison oak or poison sumack
  • 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
  • befor applying wash affected area 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 - ask a doctor

Other information

store at room temperature (59°-77° F)

Inactive ingredients

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

This product is not manufactured or distributed by Valeant Pharmaceuticals, distributor of Caladryl Clear Lotion*

DISTRIBUTED BY
FOODHOLD U.S.A., LLC
LANDOVER, MD 20785
1-877-846-9949
QUALITY GUARANTEED OR YOUR MONEY BACK

PACKAGE LABEL

CAREONE

Clear Anti-Itch Lotion

EXTERNAL ANALGESIC/SKIN PROTECTANT

Drying Action Plus Itch Relief

PRAMOXINE HCl 1%

ZINC ACETATE 0.1%

Compare to the active ingredents of Caladryl Clear Lotion*

6 FL OZ (177mL)

218.001/218AE

CLEAR ANTI-ITCH 
pramoxine hcl, zinc acetate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-218
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE1 mg  in 1 mL
ZINC ACETATE (ZINC CATION) ZINC ACETATE0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
CAMPHOR (SYNTHETIC) 
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:41520-218-30177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34703/22/2016
Labeler - Foodhold U.S.A. LLC (809183973)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(41520-218)

 
Foodhold U.S.A. LLC

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Medically reviewed on Oct 18, 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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