Label: ELITE WIPES- ethyl alcohol cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 81682-001-02, 81682-001-03, 81682-001-04, 81682-001-05, view more81682-001-06 - Packager: PROKIM KAGITCILIK VE KIMYEVI MADDELER LIMITED SIRKETI
- 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 April 1, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
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Warnings
Flammable, keep away from fire/flame
For external use onlyDo not use
• in children less than 2 months of age
• on open skin woundsWhen using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water
Stop use and ask a doctor if
• irritation and redness develop
• condition persists for more than 72 hours - Directions
- Other information
- Inactive ingredients
- Questions? +1-888-401-1003
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SPL UNCLASSIFIED SECTION
70% ALCOHOL
ETHYL ALCOHOL ANTISEPTIC HAND SANITIZING WIPES
Moisturizing with Aloe Vera
100% FRESH UNTIL OPENED
DISSIPATING ALCOHOL
OUR WIPES 100%FRESH
INDIVIDUAL PACKET
Soft Individually Wrapped Sanitizing Wipes
www.astro-us.com
Manufactured for: Aksoylu Properties, 9705 Liberia Avenue, Unit 299, Manassas, Virginia 20110
COUNTRY OF ORIGIN: TURKEY
astro® - Packaging
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INGREDIENTS AND APPEARANCE
ELITE WIPES
ethyl alcohol clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81682-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81682-001-02 10 in 1 BOX 04/01/2021 1 1 in 1 PACKET 1 4 mL in 1 PACKAGE; Type 0: Not a Combination Product 2 NDC:81682-001-03 20 in 1 BOX 04/01/2021 2 1 in 1 PACKET 2 4 mL in 1 PACKAGE; Type 0: Not a Combination Product 3 NDC:81682-001-04 50 in 1 BOX 04/01/2021 3 1 in 1 PACKET 3 4 mL in 1 PACKAGE; Type 0: Not a Combination Product 4 NDC:81682-001-05 100 in 1 BOX 04/01/2021 4 1 in 1 PACKET 4 4 mL in 1 PACKAGE; Type 0: Not a Combination Product 5 NDC:81682-001-06 250 in 1 BOX 04/01/2021 5 1 in 1 PACKET 5 4 mL in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/01/2021 Labeler - PROKIM KAGITCILIK VE KIMYEVI MADDELER LIMITED SIRKETI (595754780) Establishment Name Address ID/FEI Business Operations PROKIM KAGITCILIK VE KIMYEVI MADDELER LIMITED SIRKETI 595754780 manufacture(81682-001)