144 Remedy Clinical Zinc Oxide Paste

144 Remedy Clinical Zinc Oxide Paste
SPL v3
SPL
SPL Set ID 087d66ff-1a8c-dcb2-e063-6294a90a2f8c
Route
TOPICAL
Published
Effective Date 2023-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
White Petrolatum (57 g) Zinc Oxide (17 g)
Inactive Ingredients
Vanilla Olive Oil Coconut Oil Aphanizomenon Flosaquae Medium-chain Triglycerides Starch, Corn Ethylene Brassylate Clove Green Tea Leaf Dimethicone Glycerin Hydrolyzed Soy Protein (enzymatic; 2000 Mw) Isopropyl Myristate Water Corn Oil Honey Paraffin Methyl Dihydrojasmonate (synthetic) Yeast, Unspecified Lecithin, Soybean Alpha-tocopherol Acetate 7-dehydrocholesterol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-01

Description

White petrolatum 57% w/w Zinc oxide 17% w/w

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

White petrolatum 57% w/w Zinc oxide 17% w/w

Uses
  • temporarily protects and helps relieve chapped or cracked skin
  • temporarily protects minor cuts, scrapes, and burns
  • helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness
Warnings

For external use only.

Directions
  • for skin protection: apply as needed
  • for diaper rash: change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Do Not Use On
  • deep or puncture wounds
  • animal bites
  • serious burns
Package Label

Other Information
  • protect from freezing, avoid excessive heat
Active Ingredients

White petrolatum 57% w/w

Zinc oxide 17% w/w

Inactive Ingredients

aphanizomemnon flos-aquae (algae) extract, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, cocos nucifera (coconut) oil, corn starch, 7-dehydrocholesterol, dimethicone, ethylene brassylate, eugenia caryophyllus (clove) flower extract, glycerin, hydrolyzed soy protein, isopropyl myristate, manuka honey, methyldihydrojasmonate, olea europaea (olive) fruit oil, paraffin wax, phospholipids, tocopherol acetate, vanilla planifolia fruit extract, water, yeast ferment extract, zea mays (corn) oil

When Using This Product
  • do not get into eyes
Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA.

www.medline.com

1-800-MEDLINE (633-5463)

REF: MSC092542

V1 RD22ULI

Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms last for 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 right away.


Structured Label Content

Uses
  • temporarily protects and helps relieve chapped or cracked skin
  • temporarily protects minor cuts, scrapes, and burns
  • helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness
Purpose

Skin protectant

Warnings

For external use only.

Directions
  • for skin protection: apply as needed
  • for diaper rash: change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Do Not Use On (Do not use on)
  • deep or puncture wounds
  • animal bites
  • serious burns
Package Label

Other Information (Other information)
  • protect from freezing, avoid excessive heat
Active Ingredients (Active ingredients)

White petrolatum 57% w/w

Zinc oxide 17% w/w

Inactive Ingredients (Inactive ingredients)

aphanizomemnon flos-aquae (algae) extract, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, cocos nucifera (coconut) oil, corn starch, 7-dehydrocholesterol, dimethicone, ethylene brassylate, eugenia caryophyllus (clove) flower extract, glycerin, hydrolyzed soy protein, isopropyl myristate, manuka honey, methyldihydrojasmonate, olea europaea (olive) fruit oil, paraffin wax, phospholipids, tocopherol acetate, vanilla planifolia fruit extract, water, yeast ferment extract, zea mays (corn) oil

When Using This Product (When using this product)
  • do not get into eyes
Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA.

www.medline.com

1-800-MEDLINE (633-5463)

REF: MSC092542

V1 RD22ULI

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms last for more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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