GERI-HYDROLAC- ammonium lactate cream

Geri-Hydrolac by

Drug Labeling and Warnings

Geri-Hydrolac by is a Otc medication manufactured, distributed, or labeled by GERITREX CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient: Ammonium lactate 12%

Purpose: Stimulates cell renewal for improved skin condition

Uses

For mosturizing and softening dry scaly skin

Directions

Apply to affected areas and rub in thoroughly, twice daily or as directed by a physician

WARNINGS

FOR EXTERNAL USE ONLY

When using this product

Avoid contact with eyes, lips or mucous membranes

Do not apply over deep or punctured wounds,

infections or lacerations.

Cautions: Irritation may occur on the face. Fair skinned individuals

may experience mild stinging. Burning or peeling may occur on sensitive or irritated skin areas.

If irritation occurs, Discontinue use immediately and consult a physcian for appropiate therapy.

Inactive Ingredient

Water, Light mineral oil, Petrolatum, Peg 100 stearate, Propylene Glycol,
Oleth 5, Glycerin, cetyl Alcohol, DMDM Hydantoin, Magnesium Aluminum silicate, Methyl and propyl paraben,
Guarcel

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In the event of accidental ingestion contact a posion control center right away.

STORAGE AND HANDLING

Store at room temperature (59'-86'F)

DOSAGE & ADMINISTRATION

Twice daily or as directed by a physician

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GERI-HYDROLAC 
ammonium lactate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMMONIUM LACTATE (UNII: 67M901L9NQ) (LACTIC ACID - UNII:33X04XA5AT)	LACTIC ACID	12 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
PEG-100 STEARATE (UNII: YD01N1999R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LAURETH-4 (UNII: 6HQ855798J)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
DMDM HYDANTOIN (UNII: BYR0546TOW)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
GUAR GUM (UNII: E89I1637KE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-012-50	50 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		06/25/2013

Labeler - GERITREX CORP (112796248)

Registrant - GERITREX CORP (112796248)

Establishment
Name	Address	ID/FEI	Business Operations
GERITREX CORP		112796248	manufacture(54162-012)