ASTONEA SKIN PROTECTANT- zinc oxide ointment

Astonea Skin Protectant by

Drug Labeling and Warnings

Astonea Skin Protectant by is a Otc medication manufactured, distributed, or labeled by ASTONEA LABS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc Oxide (1.8% w/w)

Purpose

Skin Protectant

Uses:

• Helps treat and prevent diaper rash, incontinence or exposure to feces and urine
• Protects Skin against irritation due to such rash and
• Helps protect skin from exposure to wetness

Warnings:

For external use only

When using this product

• Avoid contact with eyes
• If eye contact occurs, flush with water

Stop use and ask a doctor if:

• Condition worsens or does not improve within seven days

Keep out of reach of children

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

Directions:

• Change wet or solied diapers promptly
• Clean diaper area with a mild cleanser, paying special attention to the perinium, buttocks, lower abdomen and inner thighs
• Allow to dry
• Apply to affected area as often as necessary or with each diaper change, especially at bedtime or any time when exposure to soiled diapers may be prolonged

Other information:

• Store at room temperature 15º - 30ºC (59º - 86ºF)
• Avoid excessive heat

Inactive ingredients:

Aloe Barbadensis Gel, Alpha-Tocopherol(Vitamin E), Cetostearyl Alcohol, Cholecalciferol (Vitamin D), Ethylhexylglycerine, FD&C Yellow No. 5, FD&C Yellow No. 6, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Lanolin, Lavender, Mineral Oil, Paraffin, Phenoxyethanol, Sodium Benzoate, Sodium Laureth-3 Sulfate, stearic acid, Vitamin A Palmitate, Water.

Package Labeling:

INGREDIENTS AND APPEARANCE

ASTONEA SKIN PROTECTANT 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77338-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	18 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LAVENDER OIL (UNII: ZBP1YXW0H8)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN (UNII: 7EV65EAW6H)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77338-050-04	113 g in 1 TUBE; Type 0: Not a Combination Product	08/17/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	11/21/2019

Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)

Establishment
Name	Address	ID/FEI	Business Operations
ASTONEA LABS PRIVATE LIMITED		878533295	manufacture(77338-050)