Aloe Vera Gel: Package Insert and Label Information

ALOE VERA GEL- glycerin and propylene glycol gel
NINGBO JIANGBEI OCEAN STAR TRADING 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.

Active ingredients————–purpose

Glycerine……….10%

Propylene Glycol……….4%

Uses:
Keep skin moist. Recommended for repeated use.

Warnings:

Keep away from fire or flame.For external use only.Keep out of reach of children.Keep out of reach of eyes.

Directions:

Apply small amount in your palm and smear on the skin.

Other Information

Do not store above 110F(43C) May discolor certain fabric or surfaces. Harmful to wood finishes and plastics.

Children under 6 years of age should be super vised when using this product.

Inactive Ingredients:

Water,Carbomer,Aloe barbadensis leaf juice power,Edetic acid,Ethoxylated hydrogenated castor oil,Fragrance,Dimethyloldimethy hydantoin,Triethanolamine.

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ALOE VERA GEL
aloe vera gel gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:47993-220
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN (GLYCERIN) GLYCERIN 10 g in 100 g
PROPYLENE GLYCOL (PROPYLENE GLYCOL) PROPYLENE GLYCOL 4 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER 82 g in 100 g
CARBOMER 940 0.8 g in 100 g
ALOE 0.2 g in 100 g
EDETIC ACID 0.1 g in 100 g
HYDROGENATED COCONUT OIL 1 g in 100 g
AROMADENDRIN 0.5 g in 100 g
DMDM HYDANTOIN 0.5 g in 100 g
TRIETHANOLAMINE BENZOATE 0.9 g in 100 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47993-220-01 10 g in 1 TUBE None
2 NDC:47993-220-02 15 g in 1 TUBE None
3 NDC:47993-220-03 20 g in 1 TUBE None
4 NDC:47993-220-04 30 g in 1 TUBE None
5 NDC:47993-220-05 50 g in 1 TUBE None
6 NDC:47993-220-06 60 g in 1 TUBE None
7 NDC:47993-220-07 100 g in 1 TUBE None
8 NDC:47993-220-08 237 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 02/20/2015
Labeler — NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
Registrant — NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
Establishment
Name Address ID/FEI Operations
NINGBO OCEANSTAR CHEMICAL PRODUCTS CO.,LTD 544493972 manufacture (47993-220)

Revised: 12/2017 NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD

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