OTC Medication Information: B Clean Premium Hand Sanitizer

B CLEAN PREMIUM HAND SANITIZER- alcohol gel
B Holding Group LLC

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.

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

  1. Ethyl Alcohol (62%, v/v)
  2. Water (36.228% v/v).
  3. ALOE Barbadensis Leaf Juice
  4. Maltodextrin
  5. Glycerin
  6. Propylene Glycol
  7. Fragrance
  8. Acrylates/c10-30 Alkyl Arcylate Crosspolymer
  9. Triethanomine
  10. Tocopheryl Acetate

Ethyl Alcohol 62% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Do not store above 110°F
  • May discolor some fabrics

Inactive ingredients

Water (36.228% v/v).
ALOE Barbadensis Leaf Juice
Maltodextrin
Glycerin
Propylene Glycol
Fragrance
Acrylates/c10-30 Alkyl Arcylate Crosspolymer
Triethanomine
Tocopheryl Acetate

Package Label — Principal Display Panel

Fornt and Back label
(click image for full-size original)

B CLEAN PREMIUM HAND SANITIZER
ethyl alchol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:78396-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
TROLAMINE
PROPYLENE GLYCOL
CARBOMER INTERPOLYMER TYPE A (55000 CPS)
MALTODEXTRIN
GLYCERIN
ALOE VERA LEAF
WATER
.ALPHA.-TOCOPHEROL ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78396-001-59 59 mL in 1 BOTTLE, DISPENSING None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/30/2020
Labeler — B Holding Group LLC (006108561)
Registrant — B Holding Group LLC (006108561)
Establishment
Name Address ID/FEI Operations
Nantong Health & Beyond Hygienic Products Inc. 421280161 manufacture (78396-001)

Revised: 05/2020 B Holding Group LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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