CALAMINE - ferric oxide red lotion 
Family Dollar

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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Calamine Lotion
063.001/063AA

Active ingredients

Calamine 8%
Zinc oxide 8%

Purpose

Skin Protectant

Use

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

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

• shake well before using • apply as needed

Other information

store at 59⁰ - 86⁰F

Inactive ingredients

bentonite magma, calcium hydroxide, glycerin, purified water

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

500 VOLVO PKWY, CHESAPEAKE,VA 23320 USA

MADE IN THE US WITH US AND FOREIGN COMPONENTS

NOT 100% SATISFIED?

Return package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.

Principal display panel

FAMILY Wellness

CALMINE LOTION

DRYING

Calamine Topical Suspension USP

POISON IVY, OAK, AND SUMAC DRYING LOTION

6 FL OZ (177 mL)

image description

CALAMINE  
ferric oxide red lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-063
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED80 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENTONITE (UNII: A3N5ZCN45C)  
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-063-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1989
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/15/1989
Labeler - Family Dollar (024472631)
Registrant - Vi Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC790752542manufacture(55319-063)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC088520668manufacture(55319-063)

Revised: 8/2023
Document Id: 4e6b85cf-1cc0-4560-adb0-9f73783d4f28
Set id: 1a03331e-3676-451c-be22-9a547e8ae6e2
Version: 17
Effective Time: 20230807
 
Family Dollar