Label: EQUALINE- ethyl alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 41163-258-09 - Packager: SUPERVALU INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 29, 2012
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- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- WHEN USING THIS PRODUCT
- STOP USING THIS PRODUCT AND ASK DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN
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INGREDIENTS AND APPEARANCE
EQUALINE
ethyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-258 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CARBOMER 934 (UNII: Z135WT9208) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) MANNITOL (UNII: 3OWL53L36A) POWDERED CELLULOSE (UNII: SMD1X3XO9M) HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T) CHROMIC OXIDE (UNII: X5Z09SU859) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-258-09 260 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/26/2012 Labeler - SUPERVALU INC. (006961411) Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209) Establishment Name Address ID/FEI Business Operations APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture