Label: HAND AND SKIN SHIELD- dimethicone gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69570-102-11, 69570-102-12, 69570-102-13 - Packager: DCG Vision Marketing & Sales International Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 18, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(S)
- PURPOSE
- USES
- KEEP OUT OF REACH OF CHILDREN
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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
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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:
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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.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HAND AND SKIN SHIELD
dimethicone gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69570-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 1 g in 100 mL MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 0.2 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:69570-102-11 502 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/08/2015 2 NDC:69570-102-12 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/08/2015 3 NDC:69570-102-13 100 mL in 1 TUBE; Type 0: Not a Combination Product 10/11/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 04/08/2015 Labeler - DCG Vision Marketing & Sales International Ltd. (252375576)
