OTC Medication Information: Sweet Carefor Alcohol Wipes

SWEET CAREFOR ALCOHOL WIPES- alcohol cloth
Imperial Palace Commodity(shenzhen)CO.,LTD

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 FACTS

Active Ingredient(s)

• Alcohol 75% v/v.

Purpose

• Cleaning and disinfection

Uses

Packs

• Peel back lid and then label.
• Remove wipes as required.
• Replace lid and label to keep wipes moist.

Buckets

• Open the bucket lid from the top.
• Locate tear cut in the inner pouch, tear straight to open. Do not remove wipesroll from pouch.
• Pull first wipes from center of roll up through opening.
• Thread first wipe through dispensing nozzle in top of roll.
• Close the bucket lid and dispense the wipes as required.

Warnings

• For external use only.
• Store in cool and dry place.keep away from heat and direct sunlight.
• Avoid touching eyes. In case of eye contact, flush thoroughly with water.
• Avoid contact with broken skin.
• Don’t flush into toilet.
• Stop use and ask a doctor if skin irritation develops.

• In case of accidental ingestion, seekprofessional assistance or contact a Poison Control Center immediately.

Directions

• Thoroughly moisten the skin or solid surface with the product and let it dry without wiping
• For children under 6, use only under adult supervision.
• Not recommended for infants.

Inactive ingredients

• Water, Glycerin

Package Label — Principal Display Panel

53 mL NDC: 52489-001-01

285 mL NDC: 52489-001-02

1020 mL NDC: 52489-001-03

3025 mL NDC: 52489-001-04

3.6 mL NDC: 52489-001-05

4.8 mL NDC: 52489-001-06

350 mL NDC: 52489-001-07

350 mL NDC: 52489-001-08

135ml NDC:52489-001-09

720ml NDC:52489-001-12

4760ml NDC:52489-001-15

280 mL NDC: 52489-001-17

SWEET CAREFOR ALCOHOL WIPES alcohol cloth

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52489-001 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 75 mL in 100 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:52489-001-01 53 mL in 1 PACKAGE None 2 NDC:52489-001-02 285 mL in 1 PACKAGE None 3 NDC:52489-001-03 1020 mL in 1 PAIL None 4 NDC:52489-001-04 3025 mL in 1 PAIL None 5 NDC:52489-001-05 3.6 mL in 1 PACKAGE None 6 NDC:52489-001-06 4.8 mL in 1 PACKAGE None 7 NDC:52489-001-07 350 mL in 1 PACKAGE None 8 NDC:52489-001-08 350 mL in 1 PAIL None 9 NDC:52489-001-09 135 mL in 1 PACKAGE None 10 NDC:52489-001-10 265 mL in 1 PACKAGE None 11 NDC:52489-001-11 535 mL in 1 PACKAGE None 12 NDC:52489-001-12 720 mL in 1 PAIL None 13 NDC:52489-001-13 2140 mL in 1 PAIL None 14 NDC:52489-001-14 1910 mL in 1 PAIL None 15 NDC:52489-001-15 4760 mL in 1 PAIL None 16 NDC:52489-001-16 7140 mL in 1 PAIL None 17 NDC:52489-001-17 280 mL in 1 PAIL None 18 NDC:52489-001-18 560 mL in 1 PAIL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/30/2020

Labeler — Imperial Palace Commodity(shenzhen)CO.,LTD (527796368)

Registrant — Imperial Palace Commodity(Dongguan)CO.,LTD (544367643)

Establishment
Name	Address	ID/FEI	Operations
Imperial Palace Commodity(Dongguan)CO.,LTD		544367643	manufacture (52489-001)

Revised: 11/2020 Imperial Palace Commodity(shenzhen)CO.,LTD