Baby Wipes With Allantoin (Allantoin) Liquid [Yinjing Medical Technology (Shanghai) Co., Ltd.] -

BABY WIPES WITH ALLANTOIN (ALLANTOIN) LIQUID [YINJING MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD.]
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NDC	44019-400-80
Set ID	bfcbd645-6ed2-4c1a-831e-f29eb614ca58
Category	HUMAN OTC DRUG LABEL
Packager	Yinjing Medical Technology (Shanghai) Co., Ltd.
Generic Name
Product Class
Product Number
Application Number	PART347

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Baby Wipes with Allantoin
ACTIVE INGREDIENT

Allantoin 0.5%(w/w)

Skin Protectant
Uses:

Temporarily protects and helps relieve minor skin irritations
Warnings:

For external use only.

When using this product, do not get into eyes.

Stop use and ask a doctor if the rash persists for more than 7 days,
or tends to reoccur. Keep out of reach of children

Stop use and ask a doctor

if rash persists for more than 7 days, or tends to reoccur.

Keep out of reach of children.
Directions
- Open lid, remove tab ans pull wipe through
- Take wipe and rub thoroughly over the affected area
- Use as many wipes as needed
- DO NOT FLUSH,dispose of used wipes in trash
Inactive Ingredients:

Water, Propylene Glycol, Polysorbate-20, Chamomilla Recutita Water, Tocopheryl acetate, Benzalkonium chloride, Aloe barbadensis leaf juice, potassium sorbate, Sodium Benzoate, Gluconolactone.
Other Information:

Store in a cool dry place
Baby Wipes with Allantion 80 Count (44019-400-80)

INGREDIENTS AND APPEARANCE

BABY WIPES WITH ALLANTOIN
allantoin liquid

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLUCONOLACTONE (UNII: WQ29KQ9POT)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:44019-400-80	360 g in 1 BAG; Type 0: Not a Combination Product	08/03/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	08/03/2016

Labeler - Yinjing Medical Technology (Shanghai) Co., Ltd. (530501535)

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Medic