47993-220

ALOE VERA GEL- aloe vera gel 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.

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47993-220

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.

image of Aloe Vera Gel

ALOE VERA GEL
aloe vera gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47993-220
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	10 g in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	82 g in 100 g
CARBOMER 940 (UNII: 4Q93RCW27E)	0.8 g in 100 g
ALOE (UNII: V5VD430YW9)	0.2 g in 100 g
EDETIC ACID (UNII: 9G34HU7RV0)	0.1 g in 100 g
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)	1 g in 100 g
AROMADENDRIN (UNII: 7YA4640575)	0.5 g in 100 g
DMDM HYDANTOIN (UNII: BYR0546TOW)	0.5 g in 100 g
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)	0.9 g in 100 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:47993-220-01	10 g in 1 TUBE; Type 0: Not a Combination Product	07/23/2015
2	NDC:47993-220-02	15 g in 1 TUBE; Type 0: Not a Combination Product	07/23/2015
3	NDC:47993-220-03	20 g in 1 TUBE; Type 0: Not a Combination Product	07/23/2015
4	NDC:47993-220-04	30 g in 1 TUBE; Type 0: Not a Combination Product	07/23/2015
5	NDC:47993-220-05	50 g in 1 TUBE; Type 0: Not a Combination Product	07/23/2015
6	NDC:47993-220-06	60 g in 1 TUBE; Type 0: Not a Combination Product	07/23/2015
7	NDC:47993-220-07	100 g in 1 TUBE; Type 0: Not a Combination Product	07/23/2020
8	NDC:47993-220-08	237 g in 1 TUBE; Type 0: Not a Combination Product	07/23/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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)