BABY WIPES- propylene glycol cloth

Baby Wipes by

Drug Labeling and Warnings

Baby Wipes by is a Otc medication manufactured, distributed, or labeled by Shandong Yayun Sanitary Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Baby Wipes

Active Ingredient(s)

Purpose

Antiseptic, Baby Wipes

Use

Baby Wipes 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

• on open skin wounds

WHEN USING

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

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

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

Directions

• Wipe the surface of the skin and let it dry naturally
• 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)

Inactive ingredients

WATER
Aloe Barbadensis Leaf Extract
Chamomile Extract
Phenoxyethanol
DMDM Hydantoin
Ethylhexylglycerin
Benzalkonium Chloride

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

BABY WIPES 
propylene glycol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79539-401
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMOMILE (UNII: FGL3685T2X)
WATER (UNII: 059QF0KO0R)
DMDM HYDANTOIN (UNII: BYR0546TOW)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79539-401-01	1 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
2	NDC: 79539-401-02	10 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
3	NDC: 79539-401-03	20 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
4	NDC: 79539-401-04	30 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
5	NDC: 79539-401-05	40 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
6	NDC: 79539-401-06	50 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
7	NDC: 79539-401-07	60 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
8	NDC: 79539-401-08	70 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
9	NDC: 79539-401-09	80 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
10	NDC: 79539-401-10	100 in 1 BAG; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	03/30/2020

Labeler - Shandong Yayun Sanitary Products Co., Ltd. (419983491)

Establishment
Name	Address	ID/FEI	Business Operations
Shandong Yayun Sanitary Products Co., Ltd.		419983491	manufacture(79539-401)