Label: SORE NO MORE- menthol camphor gel
- NDC Code(s): 61577-2280-2, 61577-2280-4, 61577-2280-5, 61577-2280-8
- Packager: SOMBRA COSMETICS INC.
- 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 March 8, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Keep out of reach of children
- Uses
- Warnings
- Directions
-
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Camellia Sinensis
(Green Tea) Leaf Extract, Caprylyl Glycol, Capsicum Annuum Fruit
Extract, Carbomer, Citrus Aurantium Dulcis (Orange) Peel Oil,
Citrus Grandis (Grapefruit) Seed Extract, Decyl Glucoside, Glycerin,
Hamamelis Virginiana (Witch Hazel) Leaf Extract, Phenoxyethanol,
Purified Water, Rosa Damascena Flower Water, Sodium Carbonate,
Spiraea Ulmaria Flower (Queen of the Prairie) Extract, Yucca
Schidigera Root Extract - Questions or Comments
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SORE NO MORE
menthol camphor gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61577-2280 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.03 g in 1 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.03 g in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPSICUM (UNII: 00UK7646FG) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) WATER (UNII: 059QF0KO0R) GRAPEFRUIT SEED OIL (UNII: 598D944HOL) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ORANGE PEEL (UNII: TI9T76XD44) FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY) SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT) GLYCERIN (UNII: PDC6A3C0OX) WITCH HAZEL (UNII: 101I4J0U34) YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61577-2280-5 5 g in 1 POUCH; Type 0: Not a Combination Product 03/08/2023 2 NDC:61577-2280-2 58.7 g in 1 JAR; Type 0: Not a Combination Product 03/08/2023 3 NDC:61577-2280-4 113.4 g in 1 JAR; Type 0: Not a Combination Product 03/08/2023 4 NDC:61577-2280-8 226.8 g in 1 JAR; Type 0: Not a Combination Product 03/08/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/08/2023 Labeler - SOMBRA COSMETICS INC. (097464309) Establishment Name Address ID/FEI Business Operations SOMBRA COSMETICS INC. 097464309 manufacture(61577-2280) , label(61577-2280)
