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:

Label7

PSP CALAMINE 
zinc carbonate, zinc oxide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69612-016
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC CARBONATE (UNII: EQR32Y7H0M) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION76 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION76 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: 69612-016-011 in 1 BOX10/01/202105/20/2022
1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/01/202105/27/2022
Labeler - RW Consumer Products Ltd (245592118)

Revised: 5/2022