HUMCO CALAGESIC- calamine and pramoxine hydrochloride 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 Calagesic Lotion

Drug Facts

Active Ingredients

Calamine 8%

Pramoxine HCl 1%

Purpose

Skin Protectant

External analgesic

Uses

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

Warnings

For external use only. Use only as directed.

When using this product. Avoid contact with eyes and moucous membranes.

Stop ue and ask a doctor if

condition worsens. Symptoms last for more than 7days or clear up and occur again whitin a few days.

Keep out of reach of children.

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

Directions

Adults and children 2 yr. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.

Children under 2 yrs. of age. Consult a doctor before use.

Inactive Ingredients

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

Other information

Store at room temperature 15-30C (59-86F)

Good Neighbor Pharmacy Label

GNPCaldy.jpg

Leader Label

LDRCaldy.jpg

Quality Choice Label

QCCaldy.jpg

Sunmark Label

SMCaldy.jpg

Publix Label

Publix

Premier Value

PV

CVS Label

CVS

Vida Mia Label

VM

Best Choice Label

Best Choice

HEB Label

HEB

DrugMart Label

DMCaldy.jpg

Top care Label

TCCaldy.jpg

HUMCO CALAGESIC 
calamine and pramoxine hydrochloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION80 mg  in 1 mL
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
GLYCERIN (UNII: PDC6A3C0OX)  
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:0395-9111-96177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/13/2017
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(0395-9111) , analysis(0395-9111) , pack(0395-9111) , label(0395-9111)

Revised: 6/2020
Document Id: a87aa488-3028-83c5-e053-2995a90adf50
Set id: 60530c40-c34d-5abf-e053-2991aa0a8eaf
Version: 3
Effective Time: 20200619
 
Humco Holding Group, Inc.