Label: CLEAR 40- urea gel
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Contains inactivated NDC Code(s)
NDC Code(s): 81376-231-01, 81376-231-02 - Packager: SSG Ventures Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated February 10, 2021
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- Official Label (Printer Friendly)
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PRINCIPAL DISPLAY PANEL
SAFETY WARNING:
FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES. KEEP OUT OF REACH OF CHILDREN. STOP USE IF CONDITION WORSENS OR CLEARS UP AND REOCCURS
PRESERVED WATER, MINERAL OIL, PROPYLENE GLYCOL, TRIETHANOLAMINE, COCONUT OIL, EMULTHIX, CARBOMER, XANTHAN GUM, TEA TREE OIL, ALOR VERA, METHYLPARABEN, PROPYLPARABEN
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INGREDIENTS AND APPEARANCE
CLEAR 40
urea gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81376-231 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA 40 g in 40 g Inactive Ingredients Ingredient Name Strength TRIDECETH-10 (UNII: G624N6MSBA) XANTHAN GUM (UNII: TTV12P4NEE) MINERAL OIL (UNII: T5L8T28FGP) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) COCONUT OIL (UNII: Q9L0O73W7L) WATER (UNII: 059QF0KO0R) TEA TREE OIL (UNII: VIF565UC2G) Product Characteristics Color white (OPAQUE WHITE) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81376-231-01 113 g in 1 JAR; Type 0: Not a Combination Product 01/01/2021 2 NDC:81376-231-02 226 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 01/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2021 Labeler - SSG Ventures Inc (047626115) Establishment Name Address ID/FEI Business Operations SSG Ventures Inc 047626115 manufacture(81376-231)