Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a2b9c324-a0c4-4fb7-ad2f-ad33783fd04c
Route
TOPICAL
Published
Effective Date 2014-07-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (4 g)
Inactive Ingredients
Dimethicone Butylene Glycol Glyceryl Monostearate Cetyl Ethylhexanoate Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-07-03

Description

glycerin


Medication Information

Warnings and Precautions

use only as directed

avoid contact with eyes, face, wounds, damaged skin or sensitive areas. if contact occurs, flush with water for 15 minutes



Indications and Usage

massage on body for warming sensation

use apply gradually to build comfort level for warming sensation



Dosage and Administration

for external use only



Description

glycerin

Section 50565-1

keep out of reach of the children



Section 51727-6

water, isopropyl palmitate, butylene glycol, stearic acid, glyceryl stearate, cetyl alcohol, polysorbate 61, witch hazel ext, butylene glycol, pentylene glycol, petrolatum, peg-101 stearate, dimethicone, cetyl ethylhexanoate, vanillyl butyl ether, squalane, triethanolamine, carbomer, lactic acid, xanthan gum, dimethyl sulfone, acetyl glucosamine, paeonia suffruticosa root ext, scutellaria baicalensis root ext, cetyl pyridinium chloride, sodium dehydroacetate, hexylene glycol, beeswax, fragrance, disodium edta, tocopheryl acetate, hydrogenated lecithin, ceramide 4, tea-cocoyl glutamate, caprylic/capric triglyceride, cholesterol



Section 51945-4
Section 55105-1

endless effort to improve performance and passion for healthy lifestyle

Section 55106-9

glycerin


Structured Label Content

Indications and Usage (34067-9)

massage on body for warming sensation

use apply gradually to build comfort level for warming sensation



Dosage and Administration (34068-7)

for external use only



Warnings and Precautions (34071-1)

use only as directed

avoid contact with eyes, face, wounds, damaged skin or sensitive areas. if contact occurs, flush with water for 15 minutes



Section 50565-1 (50565-1)

keep out of reach of the children



Section 51727-6 (51727-6)

water, isopropyl palmitate, butylene glycol, stearic acid, glyceryl stearate, cetyl alcohol, polysorbate 61, witch hazel ext, butylene glycol, pentylene glycol, petrolatum, peg-101 stearate, dimethicone, cetyl ethylhexanoate, vanillyl butyl ether, squalane, triethanolamine, carbomer, lactic acid, xanthan gum, dimethyl sulfone, acetyl glucosamine, paeonia suffruticosa root ext, scutellaria baicalensis root ext, cetyl pyridinium chloride, sodium dehydroacetate, hexylene glycol, beeswax, fragrance, disodium edta, tocopheryl acetate, hydrogenated lecithin, ceramide 4, tea-cocoyl glutamate, caprylic/capric triglyceride, cholesterol



Section 51945-4 (51945-4)
Section 55105-1 (55105-1)

endless effort to improve performance and passion for healthy lifestyle

Section 55106-9 (55106-9)

glycerin


Advanced Ingredient Data


Raw Label Data

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