ALOE VERA GEL- aloe vera leaf gel
Yuyao Jessie Commodity 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.

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101 aloe vera gel

Active Ingredient

aloe vera leaf 5%

Purpose

moisturizing

Use

Temporarily relieves pain and itching due to

----minor skin irritations

----minor burns

----sunburn

----minor skin irritations

----minor cuts

----insect bites

WARNINGS

For external use only.

Do not use in large quantities,particulaly over raw surfaces or blistered areas

when using this product, Keep out of reach of children. If product is swallowed, get

medical help or contact a Poison Control Center right away.

keep out of reach of children

Keep out of reach of children. If product is swallowed, get

medical help or contact a Poison Control Center right away.

Directions

adults and children 2 year of age and older:apply to affected area not more than 3 to 4 times daily

children under 2 year of age :ask a doctor

Inactive ingredients

water aqua ,alcohol denat ,glycerin,polysorbate,triethanolamine,carbomer 940,tocopherol,diazolidinyl urea,fragrance ,FD&C blue,FD&C yellow

lebel

ALOE VERA GEL
aloe vera leaf gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51414-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X)	ALOE VERA LEAF	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TRIETHANOLAMINE 2-CYCLOHEXYL-4,6-DINITROPHENOLATE (UNII: N2TK31JIAH)
CARBOMER 940 (UNII: 4Q93RCW27E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
AINSLIAEA FRAGRANS TOP (UNII: TCM65O63QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51414-101-01	15 g in 1 PACKAGE; Type 0: Not a Combination Product	01/05/2018
2	NDC:51414-101-02	20 g in 1 PACKAGE; Type 0: Not a Combination Product	01/05/2018
3	NDC:51414-101-03	30 g in 1 PACKAGE; Type 0: Not a Combination Product	01/05/2018
4	NDC:51414-101-04	40 g in 1 PACKAGE; Type 0: Not a Combination Product	01/05/2018
5	NDC:51414-101-05	50 g in 1 PACKAGE; Type 0: Not a Combination Product	01/05/2018
6	NDC:51414-101-06	50 g in 1 PACKAGE; Type 0: Not a Combination Product	01/05/2018
7	NDC:51414-101-07	100 g in 1 PACKAGE; Type 0: Not a Combination Product	01/05/2018
8	NDC:51414-101-08	120 g in 1 PACKAGE; Type 0: Not a Combination Product	01/05/2018
9	NDC:51414-101-09	150 g in 1 PACKAGE; Type 0: Not a Combination Product	01/05/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	05/08/2014

Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305)

Name	Address	ID/FEI	Business Operations
Establishment
Yuyao Jessie Commodity Co.,Ltd.		529892305	manufacture(51414-101)

Revised: 12/2022

Document Id: f0031230-c4ce-612f-e053-2995a90a360e

Set id: 43a31aec-6db0-4715-bcaf-b345bf713c38

Version: 3

Effective Time: 20221217

Yuyao Jessie Commodity Co.,Ltd.