HUMCO CALACLEAR- pramoxine hydrochloride and zinc acetate lotion 
Humco Holding Group, Inc.

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Humco 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.

Label

Calaclear.jpgPRINCIPAL DISPLAY PANEL
NDC 0395-0400-96
CALACLEARTM
Lotion
6 FL OZ
(177 mL)

HUMCO CALACLEAR 
pramoxine hydrochloride and zinc acetate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-0400
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:0395-0400-96177 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 DrugM01603/25/1998
Labeler - Humco Holding Group, Inc. (825672884)
Registrant - Pharma Nobis, LLC (118564114)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Nobis, LLC118564114manufacture(0395-0400) , analysis(0395-0400) , pack(0395-0400) , label(0395-0400)

Revised: 12/2023
Document Id: 0c929258-b193-bc2f-e063-6394a90a8e47
Set id: 5fca3a73-6d66-496b-bd33-6e044f9039bc
Version: 7
Effective Time: 20231215
 
Humco Holding Group, Inc.