Label: DERMO REAL- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78009-110-01, 78009-110-02, 78009-110-03, 78009-110-06 - Packager: Saflosa Industria Real, S.A. de C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 May 20, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only. Flammable. Keep away from heat or flame.
Do not use
- In children less than 2 months of age
- on open skin wounds.
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
DERMO REAL
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78009-110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78009-110-06 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/24/2020 2 NDC:78009-110-02 960 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/24/2020 3 NDC:78009-110-03 960 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/24/2020 4 NDC:78009-110-01 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/24/2020 Labeler - Saflosa Industria Real, S.A. de C.V. (821354313) Establishment Name Address ID/FEI Business Operations Saflosa Industria Real, S.A. de C.V. 821354313 manufacture(78009-110)