Active Ingredients:

Aluminium Hydroxide Gel 2 % w/w

Purpose

Skin Protectant

Uses:

Dries the oozing, and weeping of poison ivy, poison oak, or poison sumac, or other skin irritations

Warnings:

For external use only.

■Deep or puncture wounds ■Animal bites ■Serious burns

Avoid contact with eyes. In case of contact, ﬂush thoroughly with water

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

Keep out of reach of children

In case of accidental ingestion contact a physician or Poison Control Center right away

Directions

Apply liberally to affected area as needed or as directed by a physician ■Children under 6 months: ask a doctor

Other Information

■Store at room temperature 15°-30°C (59°-86°F)

Calcium Carbonate, Cholecalciferol, Citric Acid, DMDM Hydantoin, Ethylhexylglycerin, Lanolin, Lanolin Alcohol, Magnesium Hydroxide, Petrolatum, Phenoxyethanol, Propylene Glycol, Puriﬁed Water, Retinyl Palmitate, Sodium Chloride, Sodium Laureth Sulfate, Stearyl Alcohol, Zea Mays Corn Oil, Zinc Chloride

Principal Display Panel

Principal Display and Drug Fact Panel

ASTONEAGRAN
aluminium hydroxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77338-021
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CALCIUM CARBONATE (UNII: H0G9379FGK)
LANOLIN (UNII: 7EV65EAW6H)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)
ZINC CHLORIDE (UNII: 86Q357L16B)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CORN OIL (UNII: 8470G57WFM)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:77338-021-23	113 g in 1 TUBE; Type 0: Not a Combination Product	08/18/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	08/17/2022

Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)

ASTONEA Gran