Label: GERI-HYDROLAC- ammonium lactate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 54162-012-50 - Packager: GERITREX CORP
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 25, 2013
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- Drug Facts
- Uses
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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
- KEEP OUT OF REACH OF CHILDREN
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INGREDIENTS AND APPEARANCE
GERI-HYDROLAC
ammonium lactate creamProduct 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)