Label: NATURAL CONCEPTS- ethyl alcohol gel
- NDC Code(s): 63148-530-02, 63148-530-08, 63148-530-32, 63148-530-40
- Packager: Apollo Health and Beauty Care 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 February 19, 2021
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- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Other Information
- Inactive Ingredients
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- 2oz Sanitizer
- 8oz Sanitizer
- 32oz Sanitizer
- 128oz Sanitizer
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INGREDIENTS AND APPEARANCE
NATURAL CONCEPTS
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63148-530 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 650 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) ISOPROPYL ALCOHOL (UNII: ND2M416302) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63148-530-02 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/03/2021 2 NDC:63148-530-08 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/03/2021 3 NDC:63148-530-32 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/03/2021 4 NDC:63148-530-40 3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/03/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 02/03/2021 Labeler - Apollo Health and Beauty Care Inc (201901209) Registrant - Apollo Health and Beauty Care Inc (201901209) Establishment Name Address ID/FEI Business Operations Apollo Health and Beauty Care Inc 201901209 manufacture(63148-530)