REMEDY CALAZIME SKIN PROTECTANT- calamine, menthol, white petrolatum, zinc oxide paste 
Medline Industries, LP

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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165 REMEDY Calazime Skin Protectant

Active ingredient

Calamine 3.5%

Menthol 0.2%

White Petrolatum 69%

Zinc Oxide 16.5%

Purpose

Protectant

Protectant

Prot

Protectant

Uses

Warnings

For External Use Only

Do not use

  • in the eyes
  • on deep or puncture wounds
  • on animal bites
  • on serious burns.

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator
  • Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, stop use and consult a doctor

Stop use and ask a doctor if

  • condition worsens or does not improved within 7 days
  • you experience bleeding

Keep out of reach of children.

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

Directions

Adults

Children under 12 years of age

Other information

Inactive ingredients

Aloe Barbadensis Leaf Juice, Ascorbic Acid, Ascorbyl Palmitate, Carthamus Tinctorius (Safflower) Seed Oil, Cholecalciferol, Citric Acid, Citrus Aurantium Dulcis Peel Oil, Citrus Grandis Peel Oil, Glycine, Helianthus Annuus (Sunflower) Seed Oil, Hydroxytyrosol, L-proline, L-taurine, Methylparaben, Modified Corn Starch, Methylsulfonymethane, N-acetyl-L-cysteine, Niacinamide, Olea Europaea (Olive) Fruit Oil, PEG-8, Pyridoxine Hydrochloride, Retinyl Palmitate, Tapioca Starch Polymethylsilsesquioxane, Tocopherol, Vanillin, Zea Mays (Corn) Oil.

Medline Remedy is a registered trademark of Medline Industries, Inc.
Olivamine is a registered trademark of McCord Research, Inc. Manufactured for
Medline Industries, Inc., Mundelein, IL 60060 www.medline.com
1-800-MEDLINE

Package Label

Package Label

REMEDY CALAZIME SKIN PROTECTANT 
calamine, menthol, white petrolatum, zinc oxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-165
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED0.5 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.2 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE19.5 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM69 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ORANGE OIL (UNII: AKN3KSD11B)  
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
GLYCINE (UNII: TE7660XO1C)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
HYDROXYTYROSOL (UNII: QEU0NE4O90)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
ACETYLCYSTEINE (UNII: WYQ7N0BPYC)  
NIACINAMIDE (UNII: 25X51I8RD4)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
VANILLIN (UNII: CHI530446X)  
CORN OIL (UNII: 8470G57WFM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-165-44113 g in 1 TUBE; Type 0: Not a Combination Product03/14/201803/21/2024
2NDC:53329-165-96144 in 1 BOX03/14/201812/13/2023
24 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:53329-165-023 in 1 BAG07/01/2021
3NDC:53329-165-44113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/23/2012
Labeler - Medline Industries, LP (025460908)
Registrant - Medline Industries, LP (025460908)

Revised: 8/2023
Document Id: 026e0b60-5505-4a2f-e063-6394a90a1cc9
Set id: 1295cfcc-5b61-481b-964b-f53ffd0cb58e
Version: 7
Effective Time: 20230808
 
Medline Industries, LP