Baby Head and Body Jelly Wash: Package Insert and Label Information

BABY HEAD AND BODY JELLY WASH — glycerin liquid
And Us 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.

glycerin

water, butylene glycol, etc.

skin protectant

keep out of reach of the children

apply proper amount to the skin

1. Do not use in the following cases(Eczema and scalp wounds)
2.Side Effects
1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
3.General Precautions
1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
2)This product is for exeternal use only. Do not use for internal use
4.Storage and handling precautions
1)If possible, avoid direct sunlight and store in cool and area of low humidity
2)In order to maintain the quality of the product and avoid misuse
3)Avoid placing the product near fire and store out in reach of children

for external use only

package label
(click image for full-size original)
BABY HEAD AND BODY JELLY WASH
glycerin liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70353-0009
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN (GLYCERIN ) GLYCERIN 10 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
BUTYLENE GLYCOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70353-0009-1 350 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 12/25/2015
Labeler — And Us Co., Ltd (688461137)
Registrant — And Us Co., Ltd (688461137)
Establishment
Name Address ID/FEI Operations
And Us Co., Ltd 688461137 manufacture (70353-0009)

Revised: 12/2015 And Us Co., Ltd

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