Label: HAND-E XL- alcohol gel
- NDC Code(s): 62257-606-17, 62257-606-24, 62257-606-28, 62257-606-30
- Packager: ABC Compounding Co., 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 December 31, 2018
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- Drug Facts Box OTC-Active Ingredient Section
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- Drug Facts Box OTC-Indications & Usage Section
- Drug Facts Box OTC-Warnings Section
- Drug Facts Box OTC-When Using Section
- Drug Facts Box OTC-Stop Use Section
- Drug Facts Box OTC-Keep Out of Reach of Children Section
- Drug Facts Box OTC-Dosage & Administration Section
- Drug Facts Box OTC-Inactive Ingredient Section
- Hand-E XL 6605 Drug Facts and Label
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INGREDIENTS AND APPEARANCE
HAND-E XL
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62257-606 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOMER 934 (UNII: Z135WT9208) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) DMDM HYDANTOIN (UNII: BYR0546TOW) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) DIISOPROPYLAMINE (UNII: BR9JLI40NO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62257-606-17 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/01/2005 2 NDC:62257-606-24 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/01/2005 3 NDC:62257-606-28 149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/01/2005 4 NDC:62257-606-30 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/01/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/01/2005 Labeler - ABC Compounding Co., Inc. (003284353) Registrant - ABC Compounding Co., Inc. (003284353) Establishment Name Address ID/FEI Business Operations ABC Compounding Co., Inc. 003284353 manufacture(62257-606)