MEDLINE- menthol, white petrolatum, zinc oxide paste

Medline by

Drug Labeling and Warnings

Medline by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Menthol 0.44% w/w

White petrolatum 53% w/w

Zinc oxide 20.6% w/w

Purpose

Analgesic

Protectant

Protectant

Uses

• for the temporary relief of anorectal itching and discomfort in the perianal area associated with anorectal inflammation
• temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues
• temporarily protects irritated areas
• temporarily relieves burning
• provides temporary relief from skin irritations
• temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful
• temporarily protects inflamed perianal skin
• temporarily relieves the symptoms of perianal skin irritation
• may provide a cooling sensation

Warnings

For external use only

Allergy Alert: 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, discontinue use and consult a doctor

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

When using this product

• do not get into eyes
• 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 applicator

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days
• in case of bleeding

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

• adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply to the affected area up to 6 times daily
• Children under 12 years of age: consult a doctor
  

Other information

• protect from freezing
• avoid excessive heat
• not made with Natural rubber Latex

Inactive ingredients

7-dehydrocholesterol, algae extract (aphanizomenon flos-aquae), beeswax, bisabolol, brassica campestris (rapeseed) sterols, calamine, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, carthamus tinctorius (safflower) seed oil, cetylhydroxyproline palmitamide, cholecalciferol, cocos nucifera (coconut) oil, dimethicone, eugenia caryophyllus (clove) flower extract, glycerin, hexyldecanol, hydrolyzed soy protein, manuka honey, olea europaea (olive) oil, phospholipids, phytonadione, simmondsia chinensis (jojoba) seed oil, stearic acid, tocopheryl acetate, water, yeast ferment extract, zea mays (corn) oil, zea mays (corn) starch.

Manufacturing information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA of domestic and imported materials

1-800-MEDLINE (633-5463)

V1 RJ22PUA

REF: MSC092554PACK

Package Label

INGREDIENTS AND APPEARANCE

MEDLINE 
menthol, white petrolatum, zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-156
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	206 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4.4 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	530 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
PHYTONADIONE (UNII: A034SE7857)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
CORN OIL (UNII: 8470G57WFM)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
COCONUT OIL (UNII: Q9L0O73W7L)
GLYCERIN (UNII: PDC6A3C0OX)
HEXYLDECANOL (UNII: 151Z7P1317)
HONEY (UNII: Y9H1V576FH)
OLIVE OIL (UNII: 6UYK2W1W1E)
JOJOBA OIL (UNII: 724GKU717M)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)
APHANIZOMENON FLOSAQUAE (UNII: 49VG1X560X)
YELLOW WAX (UNII: 2ZA36H0S2V)
RAPESEED STEROL (UNII: B46B6DD20U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STARCH, CORN (UNII: O8232NY3SJ)
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
LEVOMENOL (UNII: 24WE03BX2T)
SAFFLOWER OIL (UNII: 65UEH262IS)
DIMETHICONE (UNII: 92RU3N3Y1O)
CLOVE (UNII: K48IKT5321)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-156-83	4 g in 1 PACKET; Type 0: Not a Combination Product	04/01/2023
2	NDC: 53329-156-96	144 in 1 BOX	04/01/2023
2	NDC: 53329-156-83	4 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 53329-156-14	57 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2024
4	NDC: 53329-156-44	113 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	04/01/2023

Labeler - Medline Industries, LP (025460908)

Registrant - Medline Industries, LP (025460908)