HAND AND SKIN SHIELD- dimethicone gel 
DCG Vision Marketing & Sales International 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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DCG - HAND AND SKIN SHIELD (69570-102)

ACTIVE INGREDIENT(S)

MINERAL OIL 50%

PURPOSE

SKIN PROTECTANT

USES

Helps prevent and temporarily protects chafed, chapped or cracked skin. Helps prevent and protect from the drying effects of chemicals, wind and cold weather.

Keep out of reach of children.

WARNINGS

For external use only. If swallowed, do NOT induce vomiting. Rinse mouth with water. If symptoms develop seek medical attention. • When using this product, do not get into eyes. If in contact with eyes flush with water. Stop use and ask a doctor if • condition worsens • symptoms last more than 7 days or clear up and occur again within a few days

DIRECTIONS

• Clean and dry hands and skin. Apply True Effects Hand & Skin Shield™ to the palm of hand and rub thoroughly into hands and skin, making sure front and back of hands including cuticles are completely covered. Allow to dry for 3-5 minutes or until completely absorbed into skin. • After coming into contact with dangerous chemicals, wash hands thoroughly and reapply.

Other:

STORE IN A COOL PLACE AWAY FROM DIRECT SUNLIGHT

Inactive Ingredients:

Aqua/Water, Stearic Acid, Propylene Glycol, Glyceryl Stearate, Isopropyl Palmitate, Ricinus Communis (Castor) Seed Oil, Cyclopentasiloxane, Phenoxyethanol, Sodium Hydroxide, Dimethiconol, Ethylhexylglycerin, Xanthan Gum, Disodium EDTA, Simmondsia Chinensis (Jojoba) Seed Oil, Acrylates Copolymer, Aloe Barbadensis Leaf Extract.

3.38 Bottle - New

TEHSS_17FLOZ_PumpBottle_US

HAND AND SKIN SHIELD 
dimethicone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69570-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 mL
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL0.2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
JOJOBA OIL (UNII: 724GKU717M)  
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
CASTOR OIL (UNII: D5340Y2I9G)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69570-102-11502 mL in 1 BOTTLE; Type 0: Not a Combination Product04/08/2015
2NDC:69570-102-12100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/08/2015
3NDC:69570-102-13100 mL in 1 TUBE; Type 0: Not a Combination Product10/11/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/08/2015
Labeler - DCG Vision Marketing & Sales International Ltd. (252375576)

Revised: 11/2021
Document Id: d118653d-a4ed-b543-e053-2a95a90acb12
Set id: b73eb24f-6c6c-4ea9-ae6c-c0fe5547e9cd
Version: 4
Effective Time: 20211118
 
DCG Vision Marketing & Sales International Ltd.