Label: BC HYGIENE MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES- ethyl alcohol cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 81567-101-10, 81567-101-12, 81567-101-15, 81567-101-16, view more81567-101-48, 81567-101-50, 81567-101-75, 81567-101-80 - Packager: BAC & CLARK COM SH.P.K.
- 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 12, 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 only
Do 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 waterStop use and ask a doctor if
• irritation and redness develop
• condition persists for more than 72 hours -
Directions
• open the lid and pull out the first wipe
• pull wipe apart at the perforated seam
• wet hands thoroughly with product and allow to dry without wiping
• keep container tightly closed to keep wipes from drying out
• do not flush
• supervise children under 6 years of age when using this product to avoid swallowing - Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
BC HYGIENE MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES
ethyl alcohol clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81567-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength EDETIC ACID (UNII: 9G34HU7RV0) ISOPROPYL ALCOHOL (UNII: ND2M416302) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81567-101-48 48 in 1 BOX 02/05/2021 1 3 mL in 1 PACKAGE; Type 0: Not a Combination Product 2 NDC:81567-101-75 75 in 1 BOX 02/05/2021 2 3 mL in 1 PACKAGE; Type 0: Not a Combination Product 3 NDC:81567-101-80 80 in 1 BOX 02/05/2021 3 3 mL in 1 PACKAGE; Type 0: Not a Combination Product 4 NDC:81567-101-10 100 in 1 BOX 02/05/2021 4 3 mL in 1 PACKAGE; Type 0: Not a Combination Product 5 NDC:81567-101-12 120 in 1 BOX 02/05/2021 5 3 mL in 1 PACKAGE; Type 0: Not a Combination Product 6 NDC:81567-101-15 150 in 1 BOX 02/05/2021 6 3 mL in 1 PACKAGE; Type 0: Not a Combination Product 7 NDC:81567-101-16 160 in 1 BOX 02/05/2021 7 3 mL in 1 PACKAGE; Type 0: Not a Combination Product 8 NDC:81567-101-50 500 in 1 BOX 02/05/2021 8 3.9 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 02/05/2021 Labeler - BAC & CLARK COM SH.P.K. (499428017) Establishment Name Address ID/FEI Business Operations BAC & CLARK COM SH.P.K. 499428017 manufacture(81567-101)
