PSP Calamine by RW Consumer Products Ltd PSP Calamine lotion

PSP Calamine by

Drug Labeling and Warnings

PSP Calamine by is a Otc medication manufactured, distributed, or labeled by RW Consumer Products Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PSP CALAMINE- zinc carbonate, zinc oxide suspension 
RW Consumer Products Ltd

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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PSP Calamine lotion

Drug Facts

Active ingredient

Calamine 7.6%

Zinc oxide 7.6%

Purpose

Poison ivy, oak  sumac drying

Use

• Dries the oozing and weeping effects of poison ivy, poison oak, and sumac

Warnings

For external use only.

When using this product

• Do not get into eyes

Stop use and ask a doctor if

• Conditions worsens
• Symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• Shake well before using
• Apply as needed

Other Information

• Store at 59°- 86°F
• Do not use if induction seal under cap is broken or missing

Inactive ingredients

bentonite magma, calcium hydroxide, glycerin, purified water

Package Labeling:

PSP CALAMINE 
zinc carbonate, zinc oxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69612-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC CARBONATE (UNII: EQR32Y7H0M) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	76 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	76 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENTONITE (UNII: A3N5ZCN45C)
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69612-016-01	1 in 1 BOX	10/01/2021	05/20/2022
1		250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/01/2021	05/27/2022

Labeler - RW Consumer Products Ltd (245592118)

Revised: 5/2022

Document Id: df73c9a6-1582-0287-e053-2995a90a562e

34390-5

Set id: cba6eee7-ee17-dd37-e053-2a95a90a8fa7

Version: 2

Effective Time: 20220520