NDC Code(s) : 0311-0714-17
Packager : Almay, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Almay Roll-On For Sensitive Skin - Fragrance-FreeALUMINUM SESQUICHLOROHYDRATE LIQUID
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0311-0714
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALUMINUM SESQUICHLOROHYDRATE(UNII: UCN889409V)
(ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V) 		ALUMINUM SESQUICHLOROHYDRATE0.25 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDTA(UNII: 9G34HU7RV0)
BEHENTRIMONIUM METHOSULFATE(UNII: 5SHP745C61)
GLYCERYL STEARATE SE(UNII: FCZ5MH785I)
WATER(UNII: 059QF0KO0R)
DI-PPG-2 MYRETH-10 ADIPATE(UNII: 4IN301M0KJ)
LAURETH-23(UNII: N72LMW566G)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
LAURETH-4(UNII: 6HQ855798J)
POLYSORBATE 20(UNII: 7T1F30V5YH)
LAURIC ACID(UNII: 1160N9NU9U)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0311-0714-1750 mL in 1 CONTAINER Type 0: Not a Combination Product01/01/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M019 01/01/2014

LABELER - Almay, Inc.(064988652)

Establishment
Name Address ID/FEI Business Operations
REVLON, INC. 809725570 manufacture(0311-0714)

PRINCIPAL DISPLAY PANEL

ALMAY ROLLON