FREDS CALAMINE- calamine 8% and zinc oxide 8% lotion
Fred's, 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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Fred's Calamine Lotion

Drug Facts

Active Ingredients

Calamine 8% and Zinc Oxide 8%

Purpose

Skin protectant

Uses

dries the oozing and weeping o poison ivy, poison oak, and poison sumac.

Warnings

For external use only. Use only as directed.

Avoid contact with eyes and mucous membranes.

Ask a doctor before using on chilren 6 months of age.

When using this product

Discontinue use if condition worsens or does not improve within 7 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

Adults and chidren 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry befroe each use. Apply lotion to the affected area using a cotton or soft cloth, as often as needed for comfort.

Children under 6 months of age: Consult a doctor before use.

Other information

Store at room temperature 13-30C (50-86F)

Inactive ingredients

Avicel, bentonite magma, calcium hydroxide, carrageenan, glycerin, purified water, and xanthan gum.

Label

FREDS CALAMINE
calamine 8% and zinc oxide 8% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55315-413
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	160 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
XANTHAN GUM (UNII: TTV12P4NEE)
CARRAGEENAN (UNII: 5C69YCD2YJ)
BENTONITE (UNII: A3N5ZCN45C)
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55315-413-96	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/13/2017	03/31/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	03/25/1998	03/31/2024

Labeler - Fred's, Inc. (005866116)

Registrant - Pharma Nobis, LLC (118564114)

Name	Address	ID/FEI	Business Operations
Establishment
Pharma Nobis, LLC		118564114	label(55315-413) , manufacture(55315-413) , analysis(55315-413) , pack(55315-413)

Revised: 3/2022

Document Id: da6acc7d-6950-8bd1-e053-2a95a90a3fb0

Set id: 5df48f74-ea90-9a01-e053-2a91aa0a7d3b

Version: 3

Effective Time: 20220317

Fred's, Inc.