PH5B ALCOHOL WIPES- alcohol wipes solution

PH5B Alcohol Wipes by

Drug Labeling and Warnings

PH5B Alcohol Wipes by is a Otc medication manufactured, distributed, or labeled by Guangzhou Shentai Hygienic Products Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol   75% v/v

Purpose

Ethyl Alcohol   Antiseptic

Use

Helps reduce bacteria that potentially can cause disease.

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

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

• Open the package lid and wipe skin until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

SPL UNCLASSIFIED SECTION

Manufactured by Guangzhou Shentai Hygienic Products Co.,Ltd
Guangzhou, Guangdong, China
Made in China

Distributed by Baifu International Trading Co.
3019 Bandini Blvd, Vernon, CA 90023
Phone: (323)269-2986
Email: baifumicahel@yahoo.com

Inactive ingredients

CETYLPYRIDINIUM CHLORIDE, PROPYLENE GLYCOL, PHENOXYETHANOL, BENZALKONIUM, GLYCERIN, ETHYLHEXYLGLYCERIN, WATER

Package Label - Principal Display Panel

NDC Number: 77119-445-50

INGREDIENTS AND APPEARANCE

PH5B ALCOHOL WIPES 
alcohol wipes solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77119-455
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
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZALKONIUM (UNII: 7N6JUD5X6Y)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77119-455-50	50 in 1 PACKAGE	05/15/2020
1		2.49 mL in 1 PATCH; 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	05/15/2020

Labeler - Guangzhou Shentai Hygienic Products Co., Ltd (529067056)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Shentai Hygienic Products Co., Ltd		529067056	manufacture(77119-455)