CALADRYL CLEAR- pramoxine hydrochloride and zinc acetate lotion 
Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.

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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Drug Facts

Active ingredientsPurpose
Pramoxine HCl 1%Topical analgesic
Zinc acetate 0.1%Skin protectant

Uses

  • temporarily relieves pain and itching associated with:
    • rashes due to poison ivy, poison oak or poison sumac
    • insect bites
    • minor skin irritation
    • minor cuts
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

For external use only.

When using this product do not get into eyes

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days
  • symptoms persist for 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 use
  • 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 20° to 25°C (68° to 77°F)

Inactive ingredients

SD alcohol 38-B, camphor, citric acid, diazolidinyl urea, fragrance, glycerin, hypromellose, methylparaben, polysorbate 40, propylene glycol, propylparaben, purified water, sodium citrate

Questions?

call 1-800-223-0182

Dist: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies Inc. Skillman, NJ 08558 USA

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

Caladryl®
Clear®
Topical Analgesic ∙ Skin Protectant
Lotion

Drying Action PLUS Itch Relief

6 FL OZ (177 mL)

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label
CALADRYL CLEAR 
pramoxine hydrochloride and zinc acetate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58232-0731
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
ZINC ACETATE (ZINC) ZINC ACETATE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Camphor (Synthetic) 
Citric Acid Monohydrate 
Diazolidinyl Urea 
Glycerin 
Hypromelloses 
Methylparaben 
Polysorbate 40 
Propylene Glycol 
Propylparaben 
Water 
Sodium Citrate 
Packaging
#Item CodePackage Description
1NDC:58232-0731-6177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34702/17/2012
Labeler - Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. (830803164)

Revised: 02/2012
Document Id: bf794ed7-028d-46fe-bff7-a9f0608e7ba3
Set id: d64086e1-8a93-4b7f-9fe3-31130858ebd6
Version: 1
Effective Time: 20120222
 
Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.