OTC Medication Information: XtraCare Foam Antibacterial Hand Wash Pink Cherry Blossom

XTRACARE FOAM ANTIBACTERIAL HAND WASH PINK CHERRY BLOSSOM- benzalkonium chloride soap
China Ningbo Shangge Cosmetic Technology Corp.

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.

Active Ingredient Purpose

Benzalkonium Chloride 0.1% …………… Antibacterial

Uses

for hand washing to decrease bacteria on the skin.

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

XtraCare® Foam Antibacterial Hand Wash

Kills 99.9% of bacteria

Compare to Lysol® foam antibacterial hand wash

pink cherry blossom

7.5 Fl Oz (221 mL)

Warnings

for external use only.

When using this product  avoid contact with eyes. In case of eye contact, flush with water.

Stop use and ask a doctor if  irritation and redness develops.

Directions

  • pump into hands
  • lather vigorously for at least 15 seconds
  • rinse hands with water

Inactive Ingredients

water, glycerin, lauramine oxide, PEG-150 distearate, cetrimonium chloride, propylene glycol, fragrance, citric acid, tetrasodium EDTA, cocamide MEA, methylchloroisothiazolinone, methylisothiazolinone, D&C red no. 33, FD&C yellow no.5

Other Information:  store at room temperature.

Questions/Comments?  1-855-345-5575

*This product is not manufactured or distributed by Reckitt Benckiser LLC, the distributor of Lysol® foam antibacterial hand wash.

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC

NORTHVILLE, MI 48168 USA

MADE IN CHINA

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XTRACARE FOAM ANTIBACTERIAL HAND WASH PINK CHERRY BLOSSOM
benzalkonium chloride soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58503-049
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.2 g in 221 g
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
LAURAMINE OXIDE
PEG-150 DISTEARATE
CETRIMONIUM CHLORIDE
PROPYLENE GLYCOL
CITRIC ACID MONOHYDRATE
EDETATE SODIUM
COCO MONOETHANOLAMIDE
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
D&C RED NO. 33
FD&C YELLOW NO. 5
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58503-049-01 221 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 01/29/2014
Labeler — China Ningbo Shangge Cosmetic Technology Corp. (529287434)
Establishment
Name Address ID/FEI Operations
China Ningbo Shangge Cosmetic Technology Corp. 529287434 manufacture (58503-049)

Revised: 09/2019 China Ningbo Shangge Cosmetic Technology Corp.

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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