CALACLEAR- pramoxine hydrochloride and zinc acetate lotion 
Humco Holding Group, 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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Private Label Calaclear

Humco Calamine Lotion

Drug Facts

Active Ingredient

Pramoxine HCl 1%

Purpose

External Analgesic

Active Ingredient

Zinc Acetate 0.1%

Purpose

Skin Protectant

Use

Dries the oozing and weeping and temporarily relieves pain and itching of poison ivy, poison oak, and poison sumac or other minor skin irritations.

Warnings

For external use only. Use only as directed.

Avoid contact with eyes and mucous membranes.

Ask a doctor before using

on children under 2 years of age.

When using this product. Discontinue use if 

condition worsens, does not improve or if symptoms persist for more than 7 days, or clear up and occur again within a few days. and consult a doctor.

Keep out of reach of children. 

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

Other Information

Inactive Ingredient

SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, Purified Water.

GNP Label

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Leader Label

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Quality Choice Label

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Sunmark Label

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Publix Label

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Premiere Value Label

PV

DDM Label

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CVS Label

CVS CalaclearCVS

Harris Teeter Label

HT

Best Choice Label

Best Choice

HEB Label

HEB

Equate Label

Equate CalaclearEquate

WM Label

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RA Label

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Top Care Label

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CALACLEAR 
pramoxine hydrochloride and zinc acetate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0395-9108-96177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/25/1998
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/25/1998
Labeler - Humco Holding Group, Inc. (825672884)
Registrant - Humco Holding Group, Inc. (825672884)
Establishment
NameAddressID/FEIBusiness Operations
Humco Holding Group, Inc.825672884manufacture(0395-9108) , analysis(0395-9108) , pack(0395-9108) , label(0395-9108)

Revised: 12/2021
Document Id: d3d10ec1-fa51-c138-e053-2a95a90a1f6e
Set id: 6051d390-ece7-1d00-e053-2a91aa0addf6
Version: 5
Effective Time: 20211223
 
Humco Holding Group, Inc.