Label: DEEP REMEDY - menthol and camphor (synthetic) gel
- Packager: SOMBRA COSMETICS INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active Ingredients
Menthol USP 3%
Camphor USP 3%Close
- Keep out of reach of children
Keep out of reach of childrenClose
Temporarily relieves minor aches and pains of muscles and joints associated with: simple backaches, arthritis, strains, bruises, and sprainsClose
For external use only. Do not use on wounds or damaged skin. When using this product: avoid bandaging tightly, avoid contact with eyes, keep out of reach of children.
Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.Close
adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.Close
- Inactive Ingredients
aloe vera extract, capsaicin, carbomer, decyl polyglucose, deinoized water, grapefruit seed extract, green tea extract, orange peel extract, queen of the prairie extract, rose water, sodium hydroxymethylglycinate, vegetable glycerin, witch hazel, yucca extractClose
- Questions or Comments
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
menthol camphor gel
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:61577-3610 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL .03 g in 1 g CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) .03 g in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF CAPSICUM CARBOMER HOMOPOLYMER TYPE C DECYL GLUCOSIDE WATER GRAPEFRUIT SEED OIL GREEN TEA LEAF ORANGE PEEL FILIPENDULA ULMARIA FLOWER ROSA CENTIFOLIA FLOWER OIL SODIUM HYDROXYMETHYLGLYCINATE GLYCERIN WITCH HAZEL YUCCA SCHIDIGERA ROOT Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61577-3610-5 5 g in 1 POUCH 2 NDC:61577-3610-2 58.7 g in 1 JAR 3 NDC:61577-3610-4 113.4 g in 1 JAR 4 NDC:61577-3610-8 226.8 g in 1 JAR 5 NDC:61577-3610-1 14.2 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/01/2013 Labeler - SOMBRA COSMETICS INC. (097464309) Registrant - SOMBRA COSMETICS INC. (097464309) Establishment Name Address ID/FEI Business Operations SOMBRA COSMETICS INC. 097464309 manufacture(61577-3610), label(61577-3610)