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NDC 75983-0006-57 ZINC-OXYDE PLUS 4.4; 206 mg/g; mg/g Details

ZINC-OXYDE PLUS 4.4; 206 mg/g; mg/g

ZINC-OXYDE PLUS is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by First Aid Research Corp.. The primary component is MENTHOL; ZINC OXIDE.

Product Information

NDC	75983-0006
Product ID	75983-006_d8c30b8c-dac8-183a-e053-2a95a90a6a54
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	ZINC-OXYDE PLUS
Proprietary Name Suffix	n/a
Non-Proprietary Name	MENTHOL, ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	4.4; 206
Active Ingredient Units	mg/g; mg/g
Substance Name	MENTHOL; ZINC OXIDE
Labeler Name	First Aid Research Corp.
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part346
Listing Certified Through	2023-12-31

Package

Package Images

NDC 75983-0006-57 (75983000657)

Pricing Information	N/A
NDC Package Code	75983-006-57
Billing NDC	75983000657
Package	1 TUBE in 1 CARTON (75983-006-57) / 57 g in 1 TUBE
Marketing Start Date	2019-11-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cbd899ca-80da-4a1b-9b32-2148759d9424 Details

Drug Facts

Active ingredients

Menthol 0.44%

Zinc Oxide 20.6%

Purpose

External analgesic / Anti-itch

Skin protectant / Anorectal astringent

Uses

A moisture barrier that prevents and helps heal skin irritation from: • urine • diarrhea • perspiration • fistula damage • feeding tube site leakage • wound drainage (peri-wound skin) • minor burns • cuts • scrapes • itching

Warnings

For external use only

• not for deep or puncture wounds

• avoid contact with eyes

Stop use and ask a doctor

• if condition worsens or does not improve within 7 days.

Keep out of reach of children. In case of accidental ingestion contact a physician or poison control center immediately.

Directions

cleanse skin gently with mild skin cleanser
pat dry or allow to air dry
apply a thin layer of ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.

Inactive ingredients

butylated hydroxytoluene, calamine, cetyl esters, glycerin, glycerol monostearate, lanolin, PEG-40 hydrogenated castor oil, phenol, sodium bicarbonate, thymol, white petrolatum

Questions?

call 516-783-0274

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZINC-OXYDE PLUS

menthol, zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75983-006
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4.4 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	206 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETYL ESTERS WAX (UNII: D072FFP9GU)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LANOLIN (UNII: 7EV65EAW6H)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
PHENOL (UNII: 339NCG44TV)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
THYMOL (UNII: 3J50XA376E)
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75983-006-57	1 in 1 CARTON	11/06/2019
1		57 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	11/06/2019

Labeler - First Aid Research Corp. (089405927)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Name	Address	ID/FEI	Business Operations
Establishment
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(75983-006)

Revised: 2/2022

Document Id: d8c30b8c-dac8-183a-e053-2a95a90a6a54

Set id: cbd899ca-80da-4a1b-9b32-2148759d9424

Version: 3

Effective Time: 20220224